Syringe with integral easy-open cap

Abstract

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 also includes a plunger positioned in the barrel for discharging fluid from the barrel through the distal opening, and a cap connected to the distal end of the barrel and including a connector 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 to the flow channel of the connector and a second position in which fluid may flow through the distal opening of the barrel to the flow channel of the connector.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to Indian Patent Application No. 202211035495 filed on June 21, 2022, titled “Syringe with Integrated Easy-Open Cap”, 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, such as prefilled syringes, and more particularly to syringes having an integral cap that can be easily opened by a user, preferably with one hand.

[0006] Description of Related Technology

[0007] Conventional syringes include a barrel having an open proximal end and an opposite distal end. A distal tip (sometimes referred to as a Luer piece) extends 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. During the manufacturing process, these conventional syringes are typically pre-filled with a medical fluid, such as a flushing solution or a therapeutic agent. When the syringe barrel is pre-filled with a medical fluid, the syringe barrel can be sealed to prevent contamination of the medical fluid or loss of the medical fluid before use. The seal also prevents unnecessary exposure of practitioners to the medical fluid contained in the syringe barrel, which is particularly important for toxic or otherwise harmful drugs.

[0008] Some pre-filled syringes have stops or closures, which are usually referred to as end caps, mounted on the distal end of the syringe barrel for sealing the syringe barrel, thereby preventing leakage and avoiding contamination of the medical fluid contained in the syringe barrel. Shortly before using the syringe, the end cap of the prior art is removed from the distal end of the syringe barrel by the practitioner by grabbing the end cap and pulling the end cap axially away from the syringe. When the pre-filled syringe is covered with the end cap, it is particularly important to maintain a good seal. This is usually achieved by tightly fixing the end cap to the distal end of the syringe barrel. However, when over-tightening, the end cap may be difficult to remove or may be damaged. In addition, the pre-filled syringe can be autoclaved after filling and capping, so that the pre-filled syringe is contained in a sterile package. The autoclave process may cause the interaction between the end cap and the syringe barrel, which further increases the difficulty of removing the end cap from the distal end of the syringe barrel.

[0009] Due to the tight connection between the tip cap and the distal end of the syringe barrel, the practitioner may need to apply considerable gripping force to remove the tip cap from the distal end of the syringe barrel. For some practitioners who may lack the physical strength and flexibility required to properly grip the tip cap, tightly grasping the tip cap may be difficult, especially considering the small size of typical tip caps. In addition, when tightly grasping the tip cap, the practitioner's fingers are very close to the distal end of the syringe barrel. Therefore, there is a risk that when the practitioner removes the tip cap, the practitioner will contact the distal end of the barrel, which may contaminate the distal end of the syringe barrel.

[0010] Once the tip cap is removed (which occurs shortly before a procedure is performed), the Luer tip at one end of the syringe barrel is exposed to a non-sterile environment, which provides an additional opportunity for undesirable contamination. In addition, in some cases, a practitioner may remove the tip cap to perform a preparatory action (e.g., flush air from the syringe barrel) and then reattach the same tip cap to the distal tip of the syringe before performing a fluid delivery procedure. This reattachment of the tip cap is yet another opportunity for contamination of the distal tip of the syringe barrel.

[0011] Prefilled syringes are typically connected to a patient via a vascular access device (VAD), such as an intravenous (IV) catheter (e.g., a peripheral catheter or a central venous catheter), and are used to deliver fluids to the patient. As previously mentioned, if improperly maintained or exposed to a non-sterile environment (which can occur when practitioners manipulate the tip cap or remove the tip cap from the syringe barrel), the VAD may be contaminated, blocked by blood clots, and / or may spread infection. Many medical institutions implement aseptic techniques and procedures to avoid contamination and ensure that the VAD is used correctly and that the VAD is not blocked or infected. These procedures typically include disinfecting medical devices including the VAD and flushing the catheter with a flushing solution. Specifically, VAD practice standards typically recommend flushing procedures after catheter placement, before fluid infusion, and before and after drug administration, blood sampling, transfusion, and / or parenteral nutrition. These flushing procedures are intended to confirm catheter patency, avoid drug incompatibility, ensure that a complete drug dose is administered to the patient, prevent thrombosis, and minimize the risk of bloodstream infection caused by VAD contamination.

[0012] Although sterilization procedures implemented by medical institutions do address some contamination risks, there is still a need for improved designs for medical devices and tools that reduce the chance of contamination and simplify the use of the devices. In particular, a syringe design that ensures that the distal tip of the syringe barrel remains sterile and free of contamination throughout the fluid delivery procedure using a VAD would address many of the contamination issues that currently occur during infusion procedures. In addition, a syringe and cap design that is easy to open or remove and can be manipulated without contacting the distal tip of the syringe would reduce the common contamination risks of conventional pre-filled syringes. The syringe and integrated cap design of the present disclosure addresses these issues. Summary of the invention

[0013] 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 also includes a plunger and a cap, the plunger being positioned in the barrel for discharging a fluid from the barrel through the distal opening; the cap being connected to the distal end of the barrel and having a connector defining a flow channel through the cap. The cap is movable relative to the barrel between a first position and a second position, in which the fluid is prevented from flowing through the distal opening of the barrel to the flow channel of the connector, and in which the fluid can flow through the distal opening of the barrel to the flow channel of the connector.

[0014] According to another aspect of the present disclosure, a prefilled flushing syringe comprises: the aforementioned syringe; and a predetermined volume of fluid disposed in the barrel of the prefilled syringe. The cap of the aforementioned syringe is initially in a first position, thereby preventing the fluid in the barrel from reaching the flow channel of the connector through the open distal end portion of the barrel.

[0015] According to another aspect of the present disclosure, a method for expelling fluid from the aforementioned syringe includes: moving the cap of the aforementioned syringe from a first position to a second position so as to allow fluid to flow from the barrel to 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 expel the fluid from the barrel and through the flow channel of the connector to the vascular access device.

[0016] Non-limiting illustrative examples of embodiments of the present disclosure are now described in the following numbered items.

[0017] Article 1: A syringe comprising: a barrel including a proximal end, a distal end including a distal opening, and a sidewall extending between the proximal end and the distal end; a plunger positioned in the barrel for expelling a fluid from the barrel through the distal opening; and a cap connected to the distal end of the barrel and including a connector defining a flow channel through the cap, wherein the cap is movable relative to the barrel between a first position and a second position, in which the fluid is prevented from flowing through the distal opening of the barrel to the flow channel of the connector, and in which the fluid can flow through the distal opening of the barrel to the flow channel of the connector.

[0018] Clause 2: The syringe of clause 1, wherein the cap rotates relative to the barrel to move from the first position to the second position.

[0019] Clause 3: The syringe of Clause 1 or Clause 2, wherein the cap rotates about the longitudinal axis of the barrel to move from the first position to the second position.

[0020] Clause 4: The syringe of any one of Clauses 1 to 3, wherein the cap is configured to be manually moved from the first position to the second position.

[0021] Clause 5: The syringe of clause 4, wherein the syringe is operable with one hand to both move the cap from the first position to the second position and to expel fluid from the barrel through the flow passage of the connector by moving the plunger through the barrel.

[0022] Clause 6: The syringe of any one of clauses 1 to 5, wherein the barrel comprises at least one of polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, or acrylonitrile butadiene styrene.

[0023] Clause 7: The syringe of any one of clauses 1 to 6, wherein the barrel further comprises an annular flange around the proximal end of the barrel, the annular flange being used to grasp the barrel and the plunger to move the plunger through the barrel.

[0024] Clause 8: The syringe of any one of Clauses 1 to 7, wherein the plunger comprises a stopper positioned in the barrel and a plunger rod extending proximally from the stopper through a proximal portion of the barrel.

[0025] Clause 9: The syringe of clause 8, wherein the stopper comprises a thermoplastic elastomer, such as isoprene.

[0026] Clause 10: The syringe of clause 8 or clause 9, wherein the stopper comprises a proximal end, a distal end, and an outer surface extending between the proximal end and the distal end, the outer surface sealing against the inner surface of the barrel.

[0027] Clause 11: The syringe according to any one of Clauses 8 to 10, wherein the plunger rod includes a connector portion that is inserted into and engaged with the cavity of the stopper for securing the stopper to the plunger rod.

[0028] Clause 12: The syringe of any one of Clauses 1 to 11, wherein the connector of the cap comprises at least one of a Luer connector, a threaded connector, or a snap connector.

[0029] Article 13: The syringe according to any one of Articles 1 to 12, wherein the connector is tapered so that the outer diameter of the proximal end of the connector is greater than the outer diameter of the distal end of the connector.

[0030] Article 14: According to the syringe described in any one of Articles 1 to 13, the syringe also includes at least one seal, which is positioned between the distal opening of the barrel and the cap, and the at least one seal includes at least one hole, which is used for allowing fluid to flow from the barrel to the flow channel of the connector.

[0031] Clause 15: The syringe of Clause 14, wherein the at least one aperture of the at least one seal is offset from the longitudinal axis of the syringe and is not aligned with the distal opening of the barrel.

[0032] Clause 16: The syringe of Clause 14 or 15, wherein the at least one aperture of the at least one seal is smaller than the distal opening of the barrel.

[0033] Clause 17: The syringe of any one of Clauses 14 to 16, wherein the at least one seal comprises at least two apertures, each of the two apertures being offset from the longitudinal axis of the syringe.

[0034] Clause 18: A syringe according to any one of Clauses 14 to 17, wherein the at least one seal comprises a disk formed of a thermoplastic elastomer, the disk comprising at least two holes, the at least two holes being spaced apart from the longitudinal axis of the barrel and not aligned with the distal opening of the barrel.

[0035] Clause 19: The syringe of Clause 18, wherein the disc comprises a proximal ridge extending from a proximal surface of the disc and a distal ridge extending from a distal surface of the disc, the proximal ridge being positioned in a corresponding groove at the distal end of the barrel, the distal ridge being positioned in a corresponding groove at the proximal end of the cap.

[0036] Clause 20: The syringe of any one of Clauses 1 to 19, wherein the at least one seal comprises a static proximal seal positioned between the distal end of the barrel and the proximal end of the cap, and a rotatable distal seal positioned within the proximal open end of the cap.

[0037] Clause 21. The syringe of Clause 20, wherein the distal seal rotates with the cap and the proximal seal remains stationary when the cap moves between the first position and the second position.

[0038] Article 22: A syringe according to Article 20 or Article 21, wherein the proximal seal and the distal seal each include at least one hole, which is offset from the longitudinal axis of the syringe and is not aligned with the distal opening of the barrel, and wherein, when the cap is in the second position, the at least one hole of the distal seal is aligned with the at least one hole of the proximal seal so that fluid from the barrel passes through the hole of the proximal seal and the hole of the distal seal to reach the flow channel of the connector.

[0039] Clause 23: A system according to any one of Clauses 1 to 22, wherein the cap further comprises a shield extending around the connector, the shield comprising an inner surface, the inner surface comprising threads configured to engage threads of a female connector for securing the syringe and the cap to the female connector.

[0040] Clause 24: The syringe of clause 23, wherein the distal end of the connector protrudes beyond the distal end of the shield.

[0041] Clause 25: The syringe of clause 23 or clause 24, wherein the barrel further comprises an extension extending distally from the distal end of the barrel, and wherein the cap is connected to and at least partially surrounded by the extension.

[0042] Clause 26: The syringe of Clause 25, wherein the extension portion 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.

[0043] Clause 27: The syringe of Clause 26, wherein the cap comprises a locking ring configured to engage the cap such that the cap remains seated on the proximal end of the extension.

[0044] Article 28: A syringe according to any one of Articles 25 to 27, wherein the side wall of the barrel includes a tapered portion, which is located between the distal end of the barrel and other parts of the barrel to guide the fluid in the barrel to the distal opening of the barrel.

[0045] Clause 29: The syringe of any one of Clauses 25 to 28, wherein the cap comprises at least one protrusion extending radially outward from the shield for rotating the cap relative to the barrel.

[0046] Clause 30: The syringe of Clause 29, wherein the extension portion comprises at least one slot, and wherein the at least one protrusion of the cap extends through the slot such that the at least one protrusion can be grasped by a user to rotate the cap relative to the barrel.

[0047] Article 31: The syringe of Article 30, wherein the at least one slot extending from the distal end of the extension portion comprises an axial portion and a circumferential portion, the axial portion being used to insert the cap into the extension portion, the circumferential portion being used to rotate the cap relative to the barrel between the first position and the second position.

[0048] Clause 32: The syringe of any one of Clauses 25 to 31, wherein the extension further comprises protrusions on an inner surface of the extension for limiting rotation of a seal positioned over the distal opening of the barrel.

[0049] Clause 33: The syringe of Clause 32, wherein the protrusions comprise axially extending ridges, ribs or posts on the inner surface of the extension.

[0050] Clause 34: A syringe according to any one of clauses 1 to 33, 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.

[0051] Article 35: A prefilled flushing syringe comprising: a syringe according to any one of Articles 1 to 34; and a predetermined volume of fluid disposed in the barrel of the prefilled syringe, wherein the cap is initially in the first position, thereby preventing the fluid in the barrel from reaching the flow channel of the connector through the open distal portion of the barrel.

[0052] Clause 36: The prefilled syringe of clause 35, wherein the fluid comprises a saline flush solution.

[0053] Clause 37: The prefilled syringe of clause 35 or clause 36, wherein the fluid comprises a therapeutic agent.

[0054] Clause 38: The prefilled syringe of any one of Clauses 35 to 37, wherein the barrel contains about 1 milliliter (mL) to about 50 mL of fluid.

[0055] Article 39: A method for expelling fluid from a syringe according to any one of Articles 1 to 34, the method comprising: moving the cap from a first position to a second position so as to allow fluid to flow from the barrel to the flow channel of the connector; attaching the connector of the cap to a vascular access device (VAD); and moving the plunger through the barrel to expel fluid from the barrel and through the flow channel of the connector to the vascular access device.

[0056] Clause 40: The method of clause 39, wherein the fluid contained in the barrel of the syringe comprises a saline flush solution.

[0057] Clause 41: The method of clause 39 or clause 40, wherein the fluid contained in the barrel of the syringe comprises a therapeutic agent.

[0058] Clause 42: The method of clause 40 or clause 41, wherein the cartridge contains about 1 mL to about 50 mL of fluid.

[0059] Clause 43: The method of any one of Clauses 39 to 42, wherein the cap is manually moved from the first position to the second position by grasping a portion of the cap and rotating the cap relative to the longitudinal axis of the syringe.

[0060] Clause 44: The method of clause 43, wherein the cap is manually moved from the first position to the second position by grasping a portion of the cap with one hand.

[0061] Clause 45: The method of any of Clauses 39 to 44, further comprising advancing the plunger a short distance through the barrel to remove air from the interior of the barrel before attaching the syringe to the VAD.

[0062] Article 46: A method according to any one of Articles 39 to 45, wherein attaching the cap to the VAD includes: inserting the distal tip of the connector through the septum of the fluid port of the VAD and twisting the syringe so that the threads of the syringe engage with corresponding threads of the female connector of the VAD.

[0063] Clause 47: The method of clause 46, wherein the cap is moved from the first position to the second position by rotating the cap relative to the barrel in a first direction, and the cap is attached to the VAD by rotating the syringe in a second direction opposite to the first direction.

[0064] Clause 48: The method of any one of Clauses 39 to 47, wherein the connector comprises a male Luer connector and the cap is attached to the female Luer connector by inserting the male Luer connector into the female Luer connector of the VAD. BRIEF DESCRIPTION OF THE DRAWINGS

[0065] Figure 1A is a perspective view of a syringe including an integral cap according to one aspect of the present disclosure.

[0066] Figure 1B for Figure 1A Exploded view of the syringe and cap.

[0067] Figure 2A According to one aspect of the present disclosure Figure 1A A stereoscopic view of the barrel of a syringe.

[0068] Figure 2B for Figure 2A A stereoscopic view of the distal portion of the barrel.

[0069] Figure 2C for Figure 2A A perspective view of a cross section of the distal portion of the barrel.

[0070] Figure 3A According to one aspect of the present disclosure Figure 1A A stereoscopic view of the seal of a syringe.

[0071] Figure 3B A perspective view in cross-section of a distal portion of a syringe according to one aspect of the present disclosure showing a seal disposed near the distal end of the barrel.

[0072] Figure 4A According to one aspect of the present disclosure Figure 1A Stereoscopic view of a hat.

[0073] Figure 4B for Figure 4A A perspective view of a cross section of a cap.

[0074] Figure 4C For use Figure 4A A perspective view of the seal of the cap.

[0075] Figure 5A According to one aspect of the present disclosure Figure 1AA perspective view of a section of the distal portion of a syringe showing the cap in a closed position.

[0076] Figure 5B for Figure 5A A cross-sectional view of the distal portion of the syringe.

[0077] Figure 5C According to one aspect of the present disclosure Figure 1A A perspective view of a section of the distal portion of a syringe showing the cap in an open position.

[0078] Figure 5D for Figure 5C A cross-sectional view of the distal portion of the syringe.

[0079] Figure 6 A flow chart illustrating steps for using a syringe including an integral cap for delivering a medical fluid to a patient through a vascular access device according to one aspect of the present disclosure. DETAILED DESCRIPTION

[0080] 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.

[0081] 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 (e.g., 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 (e.g., 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.

[0082] With reference to the accompanying drawings, the present disclosure relates to a syringe 10, such as a prefilled syringe, which is configured to be used by a practitioner for delivering a medical fluid to a patient through, for example, a vascular access device (VAD). The practitioner may be, for example, a medical technician, a nurse, a physician's assistant, a physician, or other trained or untrained clinician or medical caregiver. The medical fluid may 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 may also be used with the syringe 10 of the present disclosure. The medical fluid may also be a drug, a total parenteral nutrient (TPN) liquid, or another therapeutic agent for treating a chronic or acute condition as known in the art. Exemplary therapeutic agents can include, for example, drugs, chemicals, biological or biochemical substances that achieve a desired therapeutic effect when delivered to a patient in therapeutically effective amounts.

[0083] As mentioned 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 non-contaminated before and when connected to the VAD. In addition, the syringe 10 of the present disclosure is designed to be easy to operate, particularly avoiding the difficulty of removing the end cap of a conventional pre-filled syringe. In some particularly advantageous examples, the syringe 10 of the present disclosure can be operated by a practitioner with one hand. Specifically, as further described in detail herein, the practitioner can open and close the syringe cap with one hand, such as by pressing, sliding, pulling or otherwise manipulating the projection of the syringe cap to open and close the syringe cap. In contrast, as mentioned above, for conventional pre-filled syringes, the practitioner needs to grasp the syringe barrel with one hand and grasp the end cap with the other hand so that the end cap of a close fit is pulled away from the distal end of the syringe barrel. Once the syringe cap is opened, the practitioner can discharge the medical fluid from the syringe barrel of the syringe 10 with one hand, such as by pushing a plunger or a stopper through the syringe barrel.

[0084] In some examples, the syringe 10 of the present disclosure can be provided as a pre-filled syringe containing a flushing solution or other medical fluid. The pre-filled syringe 10 can also include a cap, a clip, a retainer, and / or other packaging to hold the plunger rod in place and ensure that the flushing solution or another medical fluid does not leak from the pre-filled syringe 10 at an undesirable time (e.g., during transportation).

[0085] Syringe with integrated cap

[0086] refer to Figure 1A and Figure 1B In some examples, the syringe 10 of the present disclosure includes a barrel 12, which may include a proximal end 14, a distal opening 18 ( Figure 2C The syringe 10 also includes a distal end 16 (most clearly shown in FIG. 1 ) and a sidewall 20 extending between the proximal end 14 and the distal end 16. The syringe 10 also includes a plunger 22 positioned in the barrel 12 for expelling the medical fluid F from the barrel 12 through the distal opening 18 ( Figure 5B and Figure 5D ). The syringe 10 also includes a cap 24, a valve, a cover, a sealing device or a similar structure, which is connected to the distal end 16 of the barrel 12 for sealing the medical fluid F within the barrel 12 and for directing the fluid to flow out of the interior of the barrel 12 to discharge the medical fluid F from the barrel 12. In some examples, the cap 24 includes a connector 26 or a rod extending distally from the distal end 16 of the barrel 12. The connector 26 can be an elongated and / or tubular member that defines a flow path or flow channel 28 extending from the proximal end 30 of the cap 24 to the distal end or distal tip 32 of the connector 26. As further described in detail herein, the connector 26 can be a male needleless connector 26 that is configured to be inserted into a female needleless connector, such as a fluid port or opening of a VAD. For example, the cap 24 can be configured for use with a female needleless connector, such as a female Luer connector for a size range (female Luer lock connector sizes) allowed by various design protocols (e.g., ISO 80369-7:2016 or ISO 80369-7:2021). In some specific examples, the cap 24 can be sized to engage a female needleless connector having threads having a width of about 0.3 mm to about 1.0 mm at the crest of each thread and a width of about 0.5 mm to about 1.2 mm at the root of the thread.

[0087] When the connector 26 is inserted into the female connector, fluid communication is established between the VAD and the interior of the barrel 12 through the cap 24. In addition, the cap 24 can be in a closed position or a first position ( Figure 5A and Figure 5B ) and an open position or a second position ( Figure 5C and Figure 5D10) between a closed position or first position, in which fluid is prevented from flowing through the distal opening 18 of the barrel 12 to the flow channel 28 of the connector 26, and an open position or second position, in which fluid can flow through the distal opening 18 of the barrel 12 and the flow channel 28 of the connector 26 to the VAD. For example, the cap 24 can be configured to twist or rotate, for example, about the longitudinal axis L1 ( Figure 1A and FIG. 5A to FIG. 5D ) which rotates the cap 24 from the closed position ( Figure 5A and Figure 5B ) to the open position ( Figure 5C and Figure 5D ).

[0088] In some examples, the cap 24 is configured to be manually movable, which means that the practitioner can grasp a portion of the cap 24 and rotate, twist, slide or otherwise move the cap 24 from the closed position to the open position. In addition, as previously described, the cap 24 can be configured for one-handed operation. In particular, the practitioner ideally can move the cap 24 from the closed position to the open position with 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.

[0089] Continue to refer Figure 1A and Figure 1B as well as FIG. 2A to FIG. 2C, the barrel 12 can be a conventional fluid delivery syringe barrel for medical procedures, which is made by, for example, an injection molding process. For example, the barrel 12 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. In some examples, the barrel 12 can be a cylindrical structure or an 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 known in the art. For example, an exemplary barrel 12 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. The size of the 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 of fluid delivery procedure being performed. For example, barrel 12 can define an interior containing about 1 mL to about 50 mL of medical fluid, or preferably about 5 mL to 20 mL of medical fluid.

[0090] In some examples, the sidewall 20 of the barrel 12 includes a tapered portion 34 ( Figure 2B and Figure 2C ). For example, the tapered portion 34 can be positioned between the distal end 16 of the barrel 12 and other portions of the sidewall 20 of the barrel 12. The tapered portion 34 can be configured to direct the fluid in the barrel 12 toward the distal opening 18 of the barrel 12 for discharging the medical fluid in the barrel 12 through the distal opening 18 toward the flow passage or flow channel 28 of the connector 26. The tapered portion 34 can be shaped to reduce dead space by having an inclined or angled surface corresponding to a distal surface of a stopper or plunger 22 that moves through the interior of the barrel 12 to ensure that the 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 intended amount of fluid is discharged from the barrel 12. In some examples, the barrel 12 also includes a finger flange 36 or handle. For example, as Figure 1A and Figure 1B As shown, a finger flange 36 may extend around the proximal end 14 of the barrel 12 for grasping the barrel 12 and plunger 22 to move the plunger 22 through the barrel 12 .

[0091] Continue to refer Figure 1A and Figure 1B The syringe 10 also includes a plunger 22 configured to move through the interior of the syringe barrel 12 for aspirating a medical fluid into the interior of the syringe barrel 12 (if the syringe 10 is not a prefilled syringe 10) and / or for discharging the fluid F from the barrel 12 through the flow path or flow channel 28 of the connector 26. The plunger 22 may include a stopper 38 and a plunger rod 40, which is connected to the stopper 38 and extends from the stopper 38 through the proximal end 14 of the barrel 12. The stopper 38 may have many features of conventional syringe stops or plungers known in the art. For example, the stopper 38 may include a thermoplastic elastomer material (such as polypropylene or polyethylene) and be formed of a synthetic or natural rubber (e.g., isoprene). In addition, the stopper 38 may include a proximal surface 42 or proximal end, a distal surface 44 or distal end, and a peripheral surface 46 extending between the proximal surface 42 and the distal surface 44. The peripheral surface 46 can be configured to seal against the inner surface of the sidewall 20 of the barrel 12 to allow the medical fluid F to move through the barrel 12. In some examples, the stop 38 or angle.

[0092] The plunger 22 also includes a plunger rod 40 connected to the stopper 38. The plunger rod 40 can be, for example, an injection molded component formed of a rigid thermoplastic material, such as polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, or another thermoplastic material known in the art. The plunger rod 40 can include a distal end 48 engaged to the stopper 38. For example, the distal end 48 of the plunger rod 40 can include a connector (not shown) that is inserted into a corresponding cavity or slot on the proximal surface 42 of the stopper 38. The plunger rod 40 can also include a proximal end 50 protruding proximally through the proximal end 14 of the barrel 12 and a body extending 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 manipulating the plunger rod 40 to move the plunger rod 40 and the stopper 38 through the syringe barrel 12. Within the scope of the present disclosure, the body of the plunger rod 40 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 40 can be an I-beam shape, a hollow circle, a hollow square, a hollow rectangle, or an L-shape.

[0093] In some examples, the syringe 10 also includes a sealing portion or seal (referred to herein as a first seal or proximal seal 54 and Figure 3A), the sealing portion or seal is used to seal the distal opening 18 of the barrel 12 to ensure that the fluid flows through the distal opening 18 of the barrel 12 to the flow passage or flow channel 28 of the connector 26. The proximal seal 54 can be positioned between the distal opening 18 of the barrel 12 and the cap 24. In some examples, the proximal seal 54 includes a substantially flat sheet or disk made of a fluid-impermeable material, such as silicone, rubber, isoprene, or a similar flexible elastomer, which seals the distal end 16 of the barrel 12 and the distal opening 18. The proximal seal 54 may include one or more through holes 56, one or more openings, or one or more fluid ports, which are used to allow fluid to flow from the barrel 12 to the flow channel 28 of the connector 26. For example, as Figure 3A As shown, the proximal seal 54 includes two holes 56. The holes 56 of the proximal seal 54 can be offset from the longitudinal axis L1 ( Figure 1A and FIG. 5A to FIG. 5D ) and may not be aligned with the distal opening 18 of the barrel 12, which means that the distal opening 18 of the barrel 12 and the hole 56 of the proximal seal 54 are not centered on the same axis. In addition, as shown in the figure, for example, Figure 3A , the aperture 56 of the proximal seal 54 can be smaller than the distal opening 18 of the barrel 12 (e.g., the aperture 56 of the proximal seal 54 can have a smaller diameter and / or area than the distal opening 18 of the barrel 12). Due to the arrangement of the distal opening 18 of the barrel 12 and the aperture 56, the flow of fluid from the barrel 12 through the aperture 56 to the flow channel 28 follows a slightly tortuous path, such as Figure 5C and Figure 5D As shown by arrow A2 in FIG.

[0094] In some examples, the proximal seal 54 includes a structure for maintaining the position of the proximal seal 54 over the distal opening 18 of the barrel 12. For example, the proximal seal 54 can include a proximal ridge 58 or an O-ring extending from a proximal surface 60 of the proximal seal 54, which is positioned in a corresponding groove 62 of the distal end 16 of the barrel 12, and the proximal seal 54 can also include a distal ridge 64 extending from a distal surface 66 of the proximal seal 54, which is positioned in a corresponding groove 68 on the proximal end 30 of the cap 24. The proximal ridge 58 or O-ring surrounds the distal opening 18, thereby forming a seal around the opening 18. The seal created by the proximal ridge 58 or O-ring can prevent fluid from accumulating under the proximal seal 54, thereby helping to ensure that fluid passing through the distal opening 18 moves to the flow channel 28 of the connector 26.

[0095] refer to Figure 1A and Figure 1Bas well as Figure 4A and Figure 4B , the syringe 10 also includes a cap 24 connected to the distal end 16 of the barrel 12. For example, as described in further detail herein, the barrel 12 may include a locking structure, such as a slot, groove, stopper, protrusion, ridge or similar structure, which is used to provide a mechanical engagement between the cap 24 and the barrel 12, thereby fixing the cap 24 to the barrel 12 near the distal opening 18 of the barrel 12. The cap 24 includes a rod or connector 26 defining a flow path or flow channel 28, which allows fluid to flow from the barrel 12 through the connector 26. As previously described, in some examples, the connector 26 of the cap 24 includes a male Luer connector. In other examples, the connector 26 can be a male threaded connector, a snap connector, an elongated tube or similar connector known in the art. As used herein, "Luer connector" refers to a connector that includes a tapered portion (i.e., a Luer taper) to produce a frictional engagement between the connector 26 and a tapered cavity (e.g., a cavity of a female Luer connector) that is configured to receive and engage the male connector 26. Thus, the connector 26 of the present disclosure can be a tapered elongated structure in which the outer diameter of the proximal end of the connector 26 is greater than the outer diameter of the distal end 32 of the connector 26. The connector 26 can be configured to be directly or indirectly connected to a female connector that forms the other end passage portion of a fluid port, a valve, or a VAD. In particular, a common type of fluid port for a VAD is a pierceable septum or pre-slit septum made of rubber or another elastic material. The septum can be pierced or opened by a blunted elongated member or a truncated cone-shaped end (e.g., the distal end 32 of the connector 26) to provide fluid communication between the interior of the barrel 12 and the VAD for infusing fluid into the catheter of the VAD or withdrawing fluid from the catheter of the VAD.

[0096] In some examples, the cap 24 also includes a separate seal (referred to herein as a distal seal 70) that is inserted into the proximal end or proximal opening 30 of the cap 24. Similar to the proximal seal 54, the distal seal 70 includes a flat plate or disk having a diameter that matches the inner diameter of the cap 24. The distal seal 70 includes an opening or through hole 72, which may be similar in shape and position to the hole 56 of the proximal seal 54. FIG. 5A to FIG. 5D As shown, the distal seal 70 is positioned immediately distal to the proximal seal 54, and in some cases, may be in face-to-face contact with the proximal seal 54. As further described in detail herein, the proximal seal 54 is generally a static seal 54 and does not move or rotate when the cap 24 moves from the closed position to the open position. In contrast, the distal seal 70 inserted into the proximal opening 30 of the cap 24 is configured to rotate with the cap 24, thereby moving the distal seal 70 from the closed position to the open position.

[0097] Both the proximal seal 54 and the distal seal 70 include apertures 56, 72 for allowing fluid to flow from the barrel 12 to the connector 26. For example, Figure 3A and Figure 4C As shown, the proximal seal 54 and the distal seal 70 can each include two similarly sized through holes 56, 72. The through holes 56, 72 are each offset from the longitudinal axis L1 of the syringe 10 and are not aligned with the distal opening 18 of the barrel 12. In addition, when the cap 24 is in the closed position, the hole 56 of the proximal seal 54 is not aligned with the hole 72 of the distal seal 70, as shown in FIG. Figure 5A and Figure 5B When the cap 24 is in the open position ( Figure 5C and Figure 5D ), the hole 56 of the proximal seal 54 and the hole 72 of the distal seal 70 are axially aligned so that the fluid from the barrel 12 passes through the hole 56 of the proximal seal 54 and the hole 72 of the distal seal 70 to reach the flow channel 28 of the connector 26.

[0098] In some examples, the cap 24 also includes a shield 74 extending around the connector 26. The shield 74 can be an annular structure or a tubular structure having a proximal end connected to the proximal end of the connector 26 and an open distal end 76 surrounding or surrounding the connector 26. The shield 74 includes an inner surface having a thread 78, which is configured to engage the thread of the female connector for fixing the syringe 10 and the cap 24 to the female connector. For example, the female connector can be a female needleless connector, such as a female Luer connector, a threaded connector, or a snap connector known in the art. As previously described, the thread 78 of the shield 74 can be configured to cooperate with the female connector thread, wherein the width at the crest of each thread is about 0.3mm to about 1.0mm, and the width at the bottom of the thread is about 0.5mm to about 1.2mm.

[0099] The distal tip 32 or distal end of the connector 26 can extend distally beyond the open distal end 76 of the shield 74 so that the distal end or distal tip 32 of the connector 26 can be inserted through a cap or septum over an opening or fluid port of the female connector. In some examples, the cap 24 can be configured to rotate in a first direction 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 to rotate the cap 24 and the syringe 10 in an opposite or second direction to secure the cap 24 and the syringe 10 to the female connector for discharging fluid from the syringe 10 to the VAD.

[0100] Continue to refer Figure 1A and Figure 1B as well as FIG. 2A to FIG. 2CThe barrel 12 may further include a structure for securing the cap 24 over the distal opening 18 of the barrel 12 so that fluid flows through the distal opening 18 to the flow passage or flow channel 28 of the connector 26. For example, the barrel 12 may include an extension portion 80 extending distally from the distal end 16 of the barrel 12. Figure 1A and Figure 1B As shown, the cap 24 is connected to the extension portion 80 and is at least partially surrounded by the extension portion 80. The extension portion 80 can be an annular structure or tubular structure that includes a proximal end 82 extending from the distal end 16 of the barrel 12, an open distal end 84, and an annular sidewall 86 extending between the proximal end 82 and the distal end 84. In some examples, the cap 24 can be inserted or press-fit into the extension portion 80 through the open distal end 84 of the extension portion 80. The extension portion 80 can be integrally formed with the rest of the barrel 12, or can be a separate component that is connected to the rest of the barrel 12 by adhesive, ultrasonic welding, or other suitable connection processes known in the art.

[0101] In some examples, the extension portion 80 includes one or more slots 88 or openings extending through the sidewall 86 of the extension portion 80. The cap 24 may include one or more protrusions 90 extending radially outward from the shield 74 through the slots 88 of the extension portion 80 for rotating the cap 24 relative to the barrel 12. For example, as shown in FIG. Figure 4A As shown, the cap 24 includes two protrusions 90. Each protrusion 90 includes a beam portion 92 and a handle or handle 94, the beam portion is configured to extend through a slot in the slot 88 of the extension portion 80, and the handle or handle can be manipulated by the practitioner to move the cap 24 from the closed position to the open position. In some examples, the handle 94 may include the following surfaces: these surfaces include ridges, protrusions and similar structures to make the protrusions 88 easier to grasp and manipulate. In particular, the protrusion 90 can be configured so that the practitioner can grasp the protrusion 90 between the thumb and the index finger to rotate the cap 24 between the closed position and the open position. For example, the practitioner can grasp or press the protrusion 90 to slide the protrusion 90 through the slot 88, which rotates the cap 24 from the closed position to the open position so that the fluid can flow through the cap 24 from the barrel 12 of the syringe 10.

[0102] In some examples, the slot 88 can include an axial portion or segment that extends axially from the distal end 84 of the extension 80 through the sidewall 86. The axial portion or segment allows the cap 24 to be inserted into the extension 80 with the protrusion 90 protruding through the slot 88. The slot 88 also includes a circumferential portion or segment for rotating the cap 24 relative to the barrel 12 between the closed position and the open position.

[0103] See Figure 2C The inner surface of the extension portion 80 may include a structure for fixing the proximal seal 54 in place at the proximal end 82 of the extension portion 80. For example, Figure 2C As shown, the extension portion 80 may include protrusions on the inner surface of the extension portion 80, such as axially extending ridges 96, ribs, posts or similar structures, which are used to limit the rotation of the proximal seal 54 positioned above the distal opening 18 of the barrel 12. Figure 3A As shown, the proximal seal 54 may include a cutout 55, slot or groove positioned to receive a ridge 96 on the inner surface of the extension 80. The engagement between the cutout 55 and the ridge 96 of the proximal seal 54 maintains the positioning of the proximal seal 54 and, in particular, prevents rotation of the proximal seal 54 when the cap 24 is rotated between the closed position and the open position.

[0104] like Figure 2C As shown, the extension portion 80 may also include a raised circumferential protrusion, such as a protruding ridge or locking ring 98. The locking ring 98 may be positioned to ensure that the cap 24 and the proximal seal 54 remain against the distal end 16 of the barrel 12, thereby preventing the cap 24 and the proximal seal 54 from being lifted away from the distal opening 18 of the barrel 12 when the cap 24 is rotated between the closed position and the open position. For example, the cap 24 may include a proximal protrusion 75 extending radially outward from the outer surface of the shield 74. When the cap 24 is inserted into the extension portion 80, the protrusion 75 is deflected away from the locking ring 98 so that the cap 24 can move through the extension portion 80. When the cap 24 is fully seated in the extension portion 80, the protrusion 75 snaps into place, thereby forming a locking engagement with the locking ring 98, which secures the cap 24 in the proximal end 82 of the extension portion 80.

[0105] As previously mentioned, the distal end 16 of the barrel 12 may also include an annular groove 62 ( Figure 2C ), which receives a ridge 58 or O-ring extending from the proximal surface 60 of the proximal seal 54, which also helps maintain the position of the proximal seal 54 within the extended portion 80 of the barrel 12. As previously described, the ridge 58 or O-ring also seals the distal opening 18, thereby preventing fluid from accumulating between the distal end 16 of the barrel 12 and the proximal seal 54.

[0106] Method for expelling fluid from a syringe having an integral cap

[0107] Figure 6 A flow chart illustrating the steps of discharging fluid into a VAD using syringe 10 is shown. Figure 6As shown, at step 110, the practitioner first obtains the prefilled syringe 10, wherein the interior of the syringe barrel 12 is filled with a predetermined volume of medical fluid F. For example, the prefilled syringe 10 may contain about 1 mL to about 50 mL of medical fluid F, or preferably about 5 mL to 20 mL of medical fluid F. The cap 24 of the prefilled syringe 10 is initially in a first position or a closed position to ensure that the medical fluid F remains inside the barrel 12, thereby preventing the fluid from being contaminated and / or leaking. In this initial position or prefilled position, the stopper 38 is positioned near the proximal end 14 of the barrel 12, and the plunger rod 40 extends proximally from the stopper 38 and passes through the proximal end 14 of the barrel 12.

[0108] At step 112, the practitioner prepares the syringe 10 for use, for example by removing any packaging of the syringe 10 and removing the plunger cap (if any) that holds the plunger rod 40 in place. In the initial position, the cap 24 is in a closed position, which means that fluid cannot pass through the connector 26. Alternatively, as Figure 5A and Figure 5B As shown by arrow A1 in FIG. 2 , because the hole 72 of the distal seal 70 is not aligned with the hole 56 of the proximal seal 54 , the distal seal 70 blocks the fluid from entering the flow channel 28 of the connector 26 .

[0109] At step 114, when ready to perform a flushing or injection procedure, the practitioner moves the cap 24 to the open position. For example, the practitioner may grasp one or more of the protrusions 90 of the cap 24 between the thumb and index finger and slide the protrusions 90 through the slots 88 of the extension 80, as shown in A3 (at Figure 1A ), which causes the cap 24 to rotate from the closed position to the open position. Moving the cap 24 to the open position establishes fluid communication between the interior of the syringe barrel 12 and the flow path or flow channel 28 of the connector 26, so that the medical fluid F can be discharged from the syringe 10.

[0110] At step 116, the practitioner then pushes the stopper 38 through the barrel 12 a short distance, such as by pressing the thumb plate 52 of the plunger rod 40 while grasping the finger flange 36 of the barrel 12, such as between the ring finger and the index finger, to remove air from the interior of the syringe barrel 12. At step 118, once any air is removed from the interior of the syringe barrel 12, the practitioner then attaches the connector 26 of the cap 24 to the VAD. For example, the practitioner can insert the distal end or distal tip 32 of the connector 26 into a corresponding port or valve of the VAD, particularly a port or valve of a female needleless connector. As the syringe 10 is moved distally to press the connector 26 into the septum of the female connector, the practitioner can also move the connector 26 in direction A4 ( Figure 1AThe syringe 10 and the integral cap 24 are rotated so that the threads 78 on the inner surface of the shield 74 engage with the corresponding threads on the female connector to secure the syringe 10 and the integral cap 24 to the female connector. As previously described, the rotation direction ( Figure 1A The direction of rotation (indicated by arrow A4) can be used to move the cap 24 from the closed position to the open position Figure 1A The opposite is true (as shown by arrow A3).

[0111] At step 120, with cap 24 in the open position and attached to the VAD, the practitioner may use plunger rod 40 to move in the distal direction ( Figure 1A The stopper 38 is moved through the interior of the syringe barrel 12 (as indicated by the arrow D in the middle), thereby expelling the medical fluid F from the syringe barrel 12 and passing through the flow path or flow channel 28 of the connector 26. For example, as previously described, the practitioner can use the thumb to press the thumb pressure plate 52 of the plunger rod 40 while grasping the finger flange 36 of the syringe barrel 12 to move the plunger rod 40 in the distal direction (such as Figure 1A The stopper 38 moves distally through the syringe barrel 12 to force the medical fluid F out of the syringe barrel 12, as shown by arrow A2 (as shown in FIG. Figure 5C and Figure 5D ). The practitioner continues to move stopper 38 distally through barrel 12 until all or substantially all of the medical fluid F is discharged from barrel 12 through flow passage or flow channel 28 of connector 26 to the VAD.

[0112] At step 122, after the fluid F is expelled from the syringe barrel 12 through the connector 26, the fluid F may be expelled from the syringe barrel 12 by moving the fluid F in the direction A3 (eg, Figure 1A The syringe 10 is rotated (as shown) to loosen the threads 78 of the shield 74 from the corresponding threads of the female connector, thereby disconnecting the syringe 10 from the VAD.

[0113] As previously described, the pre-filled syringe 10 of the present disclosure can be filled with a flushing solution and used for a primary or pre-flush of the patient line of the VAD. In this case, after the flushing solution is discharged from the syringe 10, the syringe 10 can be disconnected from the female connector, and another syringe containing another medical fluid (such as a therapeutic agent) can be connected to the female connector for providing the therapeutic agent to the patient. In other examples, the pre-filled syringe 10 of the present disclosure can contain a dose of the therapeutic agent to be delivered to the patient through the VAD. In this case, the syringe 10 can be attached to the female connector after flushing to provide the therapeutic agent to the patient. In other examples, the pre-filled syringe 10 of the present disclosure can contain a flushing solution and can be used for a post-flush action. For example, after the therapeutic agent is delivered to the patient through the VAD, the pre-filled syringe 10 can be connected to the VAD. The flushing solution can be discharged from the pre-filled syringe 10 through the connector 26 and the VAD to flush any remaining therapeutic agent in the VAD to the patient, thereby ensuring that a full dose of the therapeutic agent is provided to the patient. The post-flush procedure also ensures that the patient line is clean by removing any debris or other contaminants from the patient line.

[0114] Although examples of syringes and methods of the present disclosure including an integral cap 24 are shown in the drawings and described in detail above, other examples will be apparent to and readily made by those skilled in the art without departing from the scope and spirit of the 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 range of the claims will be included within the scope of the claims.

Claims

1. A syringe, comprising: a barrel comprising a proximal end, a distal end comprising a distal opening, and a sidewall extending between the proximal end and the distal end; a plunger positioned in the barrel for expelling fluid from the barrel through the distal opening; as well as a cap connected to the distal end of the barrel and including a connector defining a flow passage through the cap, Wherein, the cap is capable of moving relative to the barrel between a first position and a second position, in which, in the first position, the fluid is prevented from flowing through the distal opening of the barrel to the flow channel of the connector, and in the second position, the fluid can flow through the distal opening of the barrel to the flow channel of the connector.

2. The syringe according to claim 1, wherein: The cap rotates relative to the barrel about a longitudinal axis of the barrel to move from the first position to the second position.

3. The syringe according to claim 1, wherein: The cap is configured to be manually moved from the first position to the second position.

4. The syringe according to claim 3, wherein: The syringe is operable with a single hand to both move the cap from the first position to the second position and to expel fluid from the barrel through the flow passage of the connector by moving the plunger through the barrel.

5. The syringe according to claim 1, wherein: The plunger includes a stopper positioned in the barrel and a plunger rod extending proximally from the stopper through a proximal end portion of the barrel.

6. The syringe according to claim 1, wherein: The connector of the cap includes at least one of a Luer connector, a threaded connector, or a snap-on connector.

7. The syringe according to claim 1 further comprises at least one seal positioned between the distal opening of the barrel and the cap, the at least one seal comprising at least one hole for allowing fluid to flow from the barrel to the flow channel of the connector.

8. The syringe according to claim 7, wherein: The at least one seal comprises at least two apertures, each of the at least two apertures being offset from a longitudinal axis of the syringe.

9. The syringe according to claim 7, wherein: The at least one seal includes a disk formed of a thermoplastic elastomer, the disk including at least two apertures spaced from a longitudinal axis of the barrel and not aligned with the distal opening of the barrel.

10. The syringe according to claim 9, wherein: The disk includes a proximal ridge extending from a proximal surface of the disk and a distal ridge extending from a distal surface of the disk, the proximal ridge being positioned in a corresponding groove in the distal end of the barrel, and the distal ridge being positioned in a corresponding groove on the proximal end of the cap.

11. The syringe according to claim 7, wherein: The at least one seal includes a static proximal seal positioned between the distal end of the barrel and the proximal end of the cap and a rotatable distal seal positioned within the proximal open end of the cap.

12. The syringe according to claim 11, wherein The proximal seal and the distal seal each include at least one aperture offset from the longitudinal axis of the syringe and not aligned with the distal opening of the barrel, and Wherein, when the cap is in the second position, the at least one hole of the distal seal is aligned with the at least one hole of the proximal seal, so that the fluid from the barrel passes through the hole of the proximal seal and the hole of the distal seal to reach the flow channel of the connector.

13. The system of claim 1, wherein: The cap also includes a shroud extending around the connector, the shroud including an inner surface including threads configured to engage threads of a female connector for securing the syringe and the cap to the female connector.

14. The syringe according to claim 13, wherein: The barrel further includes an extension portion extending distally from the distal end of the barrel, and wherein the cap is connected to and at least partially surrounded by the extension portion.

15. The syringe according to claim 14, wherein The extension portion includes 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, and Wherein, the cap includes a locking ring configured to engage the cap such that the cap remains seated on the proximal end of the extension portion.

16. The syringe according to claim 14, wherein: The cap includes at least one protrusion extending radially outward from the shield for rotating the cap relative to the barrel, wherein the extension portion comprises at least one slot, and wherein the at least one protrusion of the cap extends through the slot such that the at least one protrusion can be grasped by a user to rotate the cap relative to the barrel.

17. The syringe according to claim 14, wherein: The extension portion further includes a protrusion on an inner surface of the extension portion for limiting rotation of a seal positioned over the distal opening of the barrel, and Wherein the protrusions comprise axially extending ridges, ribs or posts on the inner surface of the extension portion.

18. The syringe according to claim 1, 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.

19. A prefilled flushing syringe comprising: The syringe according to claim 1; as well as a predetermined volume of fluid disposed in the barrel of the prefilled syringe, Wherein, the cap is initially in the first position, thereby preventing the fluid in the barrel from reaching the flow channel of the connector through the open distal end portion of the barrel.

20. A method for expelling a fluid from a syringe according to claim 1, the method comprising: moving the cap from the first position to the second position so as to allow fluid to flow from the barrel to the flow passage of the connector; attaching the connector of the cap to a vascular access device; as well as The plunger is moved through the barrel to expel the fluid from the barrel and through the flow channel of the connector to the vascular access device.

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