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 further 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, the cap 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 is able to 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. 202211035493 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 technologies

[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 dexterity 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] While sterilization procedures implemented by medical institutions do address some contamination risks, there is still a need for improved designs for medical devices that reduce the chance of contamination and simplify the use of the devices. In particular, syringe designs that ensure that the distal tip of the syringe barrel remains sterile and free of contamination throughout the fluid delivery procedure using a VAD will address many of the current contamination issues. In addition, syringe and cap designs that are easy to open or remove and can be manipulated without touching the distal tip of the syringe will 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 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, the cap having a connector that defines 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 syringe described previously; and a predetermined volume of fluid disposed in the barrel of the prefilled syringe. The cap of the syringe described previously is initially in the first position, thereby preventing the fluid in the barrel from passing through the open distal end portion of the barrel to reach the flow channel of the connector.

[0015] According to another aspect of the present disclosure, a method for expelling fluid from a previously described syringe comprises: moving the cap of the previously described syringe from the first position to the 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 will now be described in the following numbered items.

[0017] Article 1: A syringe comprises: 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, the cap comprising 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 is able to 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 enable the plunger to move 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] Item 9: The syringe of Item 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 of any one of Clauses 8 to 10, wherein the plunger rod comprises a connector portion that is inserted into the cavity of the stopper and engages the cavity of the stopper to secure 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: A 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 a barrel seal, which is positioned between the distal opening of the barrel and the cap, and the barrel seal includes at least one hole, which is used to allow fluid to flow from the barrel to the flow channel of the connector.

[0031] Clause 15: A syringe according to Clause 14, wherein the barrel seal comprises a disc-shaped portion and an annular wall portion, the disc-shaped portion being positioned over the distal end of the barrel, the annular wall portion extending from the disc-shaped portion to be positioned against the inner surface of the barrel, wherein the at least one hole extends through the disc-shaped portion.

[0032] Clause 16: The syringe of Clause 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 relative to the barrel.

[0033] Clause 17: The syringe of Clause 16, wherein the groove comprises an axial groove extending between the proximal end and the distal end of the annular wall of the barrel seal.

[0034] Clause 18: A syringe according to any one of Clauses 15 to 17, wherein the barrel seal includes an annular ridge extending proximally from the proximal surface of the disc-shaped portion, the annular ridge being received in a corresponding annular groove on the distal end of the barrel.

[0035] Clause 19: A syringe according to any one of Clauses 15 to 18, wherein the barrel seal further comprises a lip extending radially inwardly from the annular wall portion of the barrel seal, the lip being configured to engage the cap to retain the proximal portion of the cap within the barrel seal.

[0036] Article 20: According to the syringe described in any one of Articles 15 to 19, the syringe also includes a stopper, which is engaged to the cap and moves as the cap moves from the first position to the second position, wherein when the cap is in the first position, the stopper is located above the at least one hole of the barrel seal to prevent the fluid from flowing through the at least one hole of the barrel seal to the flow channel of the connector, and when the cap is in the second position, the stopper is spaced apart from the at least one hole of the barrel seal to allow the fluid to flow from the barrel through the at least one hole of the barrel seal to the flow channel of the connector.

[0037] Clause 21: The syringe of Clause 20, wherein the stopper comprises: a sealing portion that moves over the at least one hole of the barrel seal; and at least one arm that extends from the sealing portion and is engaged to a portion of the cap.

[0038] Article 22: A syringe according to Article 20 or Article 21, wherein the end of the at least one arm of the stopper is pivotally connected to the inner surface of the cap so that when the cap moves from the first position to the second position, the stopper can move to expose the at least one hole of the barrel seal.

[0039] Article 23: A syringe according to any one of Articles 20 to 22, wherein the cap includes at least one pair of protrusions extending radially inward from the inner surface of the cap, and wherein the end of the at least one arm of the stopper is positioned between the pair of protrusions so that the protrusions cause the stopper to move when the cap is rotated from the first position to the second position.

[0040] Clause 24: A syringe according to any one of Clauses 20 to 23, wherein the stopper further comprises a post inserted into the hole of the disc-shaped portion of the seal, the post forming a rotation point when the cap moves from the first position to the second position.

[0041] Clause 25: A syringe according to any one of Clauses 20 to 24, wherein the stopper comprises an elastomeric seal configured to be positioned over the 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.

[0042] Clause 26. The syringe of Clause 25, wherein the stopper further comprises a body comprising a rigid thermoplastic material, and wherein the elastomeric seal is mounted or adhered to the body of the stopper.

[0043] Clause 27: The syringe of any one of Clauses 14 to 26, wherein the at least one hole of the barrel seal is axially aligned with the distal opening of the barrel, and wherein the diameter of the at least one hole of the barrel seal is smaller than the diameter of the distal opening of the barrel.

[0044] Clause 28: The syringe of any one of Clauses 14 to 27, wherein the barrel seal comprises a thermoplastic elastomer material.

[0045] Clause 29: The syringe of any one of Clauses 14 to 28, wherein the barrel seal remains stationary when the cap moves from the first position to the second position.

[0046] Article 30: A syringe according to any one of Articles 1 to 29, wherein the cap further includes a shield extending around the connector, the shield including an inner surface, the inner surface including threads configured to engage threads of a female connector to secure the syringe and the cap to the female connector.

[0047] Clause 31: The syringe of clause 30, wherein the distal end of the connector protrudes beyond the distal end of the shield.

[0048] Clause 32: The syringe of clause 30 or clause 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.

[0049] Clause 33: The syringe of any one of Clauses 30 to 32, 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.

[0050] Clause 34: The syringe of Clause 33, 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.

[0051] Article 35: The syringe according to Article 33 or Article 34, wherein the side wall of the barrel includes a tapered portion located between the distal end of the barrel and other portions of the barrel for directing the fluid in the barrel toward the distal opening of the barrel.

[0052] Clause 36: The syringe of any one of Clauses 33 to 35, wherein the cap includes at least one protrusion extending radially outward from the shield to enable the cap to rotate relative to the barrel.

[0053] Article 37: A syringe according to any one of Articles 33 to 36, wherein the cap further comprises a rotating ring, the rotating ring comprising the at least one protrusion, wherein the rotating ring extends around the shield of the cap and the extended portion of the barrel, and wherein the rotating ring is configured to be rotated by a user to move the cap between the first position and the second position.

[0054] Clause 38: The syringe of Clause 37, wherein the cap comprises a plurality of protrusions extending radially outward from the shield, and wherein the plurality of protrusions are connected to the rotating ring at different locations around the circumference of the ring to support the rotating ring.

[0055] Clause 39: A syringe according to any one of Clauses 36 to 38, wherein the extension portion includes at least one slot, and wherein the at least one protrusion of the cap extends through the slot so that the at least one protrusion can be grasped by a user to rotate the cap relative to the barrel.

[0056] Article 40: A syringe according to Article 39, wherein the at least one narrow slot extending from the distal end of the extension portion includes: an axial portion for inserting the cap into the extension portion; and a circumferential portion for rotating the cap relative to the barrel between the first position and the second position.

[0057] Article 41: A syringe according to Article 39 or Article 40, wherein the at least one slot includes at least one protrusion that protrudes from the surface of the slot, and the at least one protrusion limits the at least one protrusion from sliding through the slot to lock the cap in the extension portion.

[0058] Article 42: The syringe according to any one of Articles 33 to 41, wherein the extension portion further comprises a protrusion located on the inner surface of the extension portion, the protrusion being used to limit the rotation of the barrel seal positioned above the distal opening of the barrel.

[0059] Clause 43: The syringe of clause 42, wherein the protrusion comprises an axially extending ridge, rib or post located on the inner surface of the extension portion.

[0060] Article 44: A prefilled flushing syringe comprising: a syringe according to any one of Articles 1 to 43; and a predetermined volume of fluid disposed in the barrel of the prefilled syringe, wherein the cap is initially located in a first position, thereby preventing the fluid in the barrel from passing through the open distal portion of the barrel to reach the flow channel of the connector.

[0061] Clause 45. The prefilled syringe of clause 44, wherein the fluid comprises a saline flush solution.

[0062] Clause 46: The prefilled syringe of clause 44 or clause 45, wherein the fluid comprises a therapeutic agent.

[0063] Clause 47: The prefilled syringe of any one of Clauses 44 to 46, wherein the barrel contains about 1 mL to about 50 mL of the fluid.

[0064] Article 48: A method for expelling fluid from a syringe according to any one of Articles 1 to 43, the method comprising: moving a cap from a first position to a second position so as to allow fluid to flow from a barrel to a flow channel of a connector; attaching the connector of the cap to a vascular access device; and moving a plunger through the barrel to expel the fluid from the barrel and through the flow channel of the connector to the vascular access device.

[0065] Clause 49: The method of clause 48, wherein the fluid contained in the barrel of the syringe comprises a saline flush solution.

[0066] Clause 50: The method of clause 48 or clause 49, wherein the fluid contained in the barrel of the syringe comprises a therapeutic agent.

[0067] Clause 51: The method of any one of Clauses 48 to 50, wherein the cartridge contains about 1 mL to about 50 mL of the fluid.

[0068] Clause 52: The method of any one of Clauses 48 to 51, 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.

[0069] Clause 53: The method of Clause 52, wherein the cap is manually moved from the first position to the second position by grasping a portion of the cap with one hand.

[0070] Clause 54: The method of any of Clauses 48 to 53, 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.

[0071] Article 55: A method according to any one of Articles 48 to 54, 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 the corresponding threads of the female connector of the VAD.

[0072] Clause 56: The method of Clause 55, 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.

[0073] Clause 57: The method of any of Clauses 48 to 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

[0074] Figure 1A is a perspective view of a syringe including an integral cap according to one aspect of the present disclosure.

[0075] Figure 1B yes Figure 1A Exploded view of the syringe and cap.

[0076] Figure 2A According to one aspect of the present disclosure Figure 1A A stereoscopic view of the barrel of a syringe.

[0077] Figure 2B yes Figure 2A A front view of the distal portion of the barrel.

[0078] Figure 2C yes Figure 2A A perspective view of a cross section of the distal portion of the barrel.

[0079] Figure 3A According to one aspect of the present disclosure Figure 1A A stereoscopic view of the distal surface of a syringe seal.

[0080] Figure 3B yes Figure 3A A stereoscopic view of the proximal surface of the seal.

[0081] Figure 3Cis a perspective view of a cross section of a distal portion of a syringe barrel showing a seal positioned proximate the distal end of the barrel according to an aspect of the present disclosure.

[0082] Figure 4A According to one aspect of the present disclosure Figure 1A A stereoscopic view of the distal portion of the cap.

[0083] Figure 4B yes Figure 4A A stereoscopic view of the proximal portion of the cap.

[0084] Figure 4C yes Figure 4A A perspective view of a cross section of a cap.

[0085] Figure 4D is a perspective view of a section of a distal portion of a syringe barrel showing a seal positioned proximate the distal end of the barrel and a cap positioned against the seal in accordance with an aspect of the present disclosure.

[0086] Figure 5A According to one aspect of the present disclosure, a method for preventing fluid from Figure 1A A perspective view of the barrel of a syringe flowing into the stopper of the cap.

[0087] Figure 5B yes Figure 5A Bottom view of the stopper.

[0088] Fig. 6A According to one aspect of the present disclosure Figure 1A A perspective view of a section of a syringe showing a seal, a stopper and a cap connected to the distal end of a barrel, with the stopper in a closed position.

[0089] Figure 6B According to one aspect of the present disclosure Figure 1A A cross-sectional view of a syringe showing a seal, a stopper and a cap connected to the distal end of a barrel, with the stopper in a closed position.

[0090] Figure 6C According to one aspect of the present disclosure Figure 1A A perspective view of a section of the distal end of a syringe showing the stopper engaged with a portion of the cap in a closed position.

[0091] Fig. 7A According to one aspect of the present disclosure Figure 1A A perspective view of a section of a syringe showing a seal, a stopper and a cap connected to the distal end of a barrel with the stopper in an open position.

[0092] Figure 7B According to one aspect of the present disclosure Figure 1AAnother cross-sectional view of a syringe of , showing the seal, stopper and cap connected to the distal end of the barrel, with the stopper in an open position.

[0093] Figure 7C According to one aspect of the present disclosure Figure 1A A cross-sectional view of the distal end of a syringe showing the stopper in an open position engaged with a portion of the cap.

[0094] Figure 8 is a flow chart illustrating steps for using a syringe including an integral cap to deliver a medical fluid to a patient through a vascular access device according to an aspect of the present disclosure. DETAILED DESCRIPTION

[0095] 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.

[0096] 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 the device 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 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.

[0097] 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.

[0098] 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.

[0099] In some examples, the syringe 10 of the present disclosure is provided as a pre-filled syringe containing a flushing solution or other medical fluid. The pre-filled syringe 10 may also include a cap, a clamp, a retainer and / or other packaging to hold the plunger rod in place and ensure that the flushing solution or other medical fluid does not leak from the pre-filled syringe 10 at an undesirable time (e.g., during transportation).

[0100] Syringe with integrated cap

[0101] refer to Figure 1A and Figure 1B 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 further 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 a medical fluid F (e.g., via the distal opening 18) from the barrel 12. Fig. 6A , Figure 6B , Fig. 7A and Figure 7B ). 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 stem extending distally from the distal end 16 of the barrel 12. The connector 26 can be an elongated member and / or a 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 described in further 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 female connector that forms 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 size) 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 bottom of the thread.

[0102] 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 (eg, FIG. 6A to FIG. 6C ) and the open position or the second position (as shown 7A to 7CThe cap 24 is configured to move 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 passage 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 passage 28 of the connector 26 to the VAD. For example, the cap 24 can be configured to surround the longitudinal axis L1 of the barrel 12 and the syringe 10 (as shown). Figure 1A , Fig. 6A , Figure 6B , Fig. 7A and Figure 7B ) to twist or rotate the cap 24 from the closed position (as shown) FIG. 6A to FIG. 6C ) to the open position (as shown) 7A to 7C shown).

[0103] In some examples, the cap 24 is configured to be manually movable, meaning that a practitioner can grasp a portion of the cap 24 and rotate, twist, slide, or otherwise move the cap 24 from a closed position to an open position. In addition, as previously described, the cap 24 can be configured for one-handed operation. In particular, the practitioner ideally can use one hand to both move the cap 24 from a closed position to an open position and to 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.

[0104] 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 applying a flushing solution to a VAD known in the art. In some examples, the barrel 12 can be a cylindrical structure or an elliptical prism 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 similar to the barrel 12 of the present disclosure is described in a U.S. patent application with publication number 2020 / 0061297 and titled "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 may be configured to contain various fluid volumes depending on the type and amount of fluid delivered to a patient from barrel 12. For example, barrel 12 may 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.

[0105] In some examples, the sidewall 20 of the barrel 12 includes a tapered portion 34 (eg, FIG. 2A to FIG. 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 guide the fluid in the barrel 12 toward the distal opening 18 of the barrel 12 to discharge the medical fluid in the barrel 12 toward the flow path or flow channel 28 of the connector 26 through the distal opening 18. The tapered portion 34 can be formed to reduce dead space by having an inclined or angled surface corresponding to the distal surface of the stopper or plunger 22, which 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 the appropriate or expected amount of fluid is discharged from the barrel 12 and delivered to the patient. In some examples, the barrel 12 also includes a finger flange 36 or a 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 to provide for grasping the barrel 12 and plunger 22 to move the plunger 22 through the barrel 12 .

[0106] Continue to refer Figure 1Aand Figure 1B , the syringe 10 also includes a plunger 22, which is configured to move through the interior of the syringe barrel 12 to draw a medical fluid into the interior of the syringe barrel 12 (if the syringe 10 is not a prefilled syringe 10) and / or to discharge 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 through the proximal end 14 of the barrel 12. The stopper 38 may have many features of conventional syringe stops or plungers as known in the art. For example, the stopper 38 may include a thermoplastic elastomer material (e.g., polypropylene or polyethylene) and be formed of a synthetic rubber 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 an outer 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, as previously described, the distal end or distal surface 44 of the stopper 38 can be tapered, having a slope or angle that matches the tapered portion 34 of the sidewall 20 of the barrel 12.

[0107] The plunger 22 also includes a plunger rod 40 connected to the stopper 38. For example, the plunger rod 40 can be an injection molded component formed of a rigid thermoplastic material, such as 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 is 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 that protrudes 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 that is used to manipulate 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 various 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.

[0108] Continue to refer Figure 1A and Figure 1B as well as FIG. 3A to FIG. 3CThe syringe 10 also includes a barrel seal 54 or gasket for sealing the distal opening 18 of the barrel 12 to ensure that the fluid passing through the distal opening 18 of the barrel 12 passes through the flow passage or flow channel 28 of the connector 26. Figure 3C As shown, the barrel seal 54 can be positioned proximate the distal opening 18 of the barrel 12 and between the distal end 16 of the barrel 12 and the cap 24. The barrel seal 54 can be formed of an elastomeric material that seals the distal end 16 of the barrel 12 and the distal opening 18, such as silicone, rubber, isoprene, or a similar flexible elastomer.

[0109] In some examples, the barrel seal 54 includes a generally planar sheet or disk portion 57 positioned above the distal end 16 of the barrel 12 and an annular wall portion 59 extending distally from the disk portion 57 and positioned against an annular inner surface of a portion of the barrel 12. The barrel seal 54 also includes an opening, perforation, or fluid port (e.g., through hole 56) extending through the disk portion 57 to allow fluid to flow from the barrel 12 to the flow passage 28 of the connector 26.

[0110] like Figure 3C As shown, the hole 56 of the barrel seal 54 can be along the longitudinal axis L1 of the syringe 10 (eg, Figure 1A , Fig. 6A , Figure 6B , Fig. 7A and Figure 7B 56) is axially aligned with the distal opening 18 of the barrel 12, 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 Figure 3C As shown, the hole 56 of the barrel seal 54 can be smaller (e.g., can have a smaller diameter and / or area) than the distal opening 18 of the barrel 12. 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 an O-ring extending from the proximal surface of the barrel seal 54, which is positioned in 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 remains 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 to prevent fluid from accumulating in the space between the distal end 16 of the barrel 12 and the barrel seal 54.

[0111] refer to FIG. 3A to FIG. 3C, the barrel seal 54 may also include a lip 61 or an inwardly directed ridge extending radially inwardly from the annular wall portion 59 of the barrel seal 54. The lip 61 may be positioned to engage the cap 24 to retain 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 in the barrel seal 54, thereby limiting the distal movement of the cap 24 away from the barrel seal 54 when the cap 24 rotates between the closed position and the open position. However, it should be noted that in some examples, when the cap 24 moves from the closed position to the open position, the cap 24 may be slightly lifted away from the barrel seal 54 to form a gap between the disc 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 limited by the engagement between the cap 54 and the lip 61.

[0112] refer to Figure 1A and Figure 1B as well as Figure 5A and Figure 5B , the syringe 10 also includes a stopper 63 or valve engaged with the cap 24. The stopper 63 is configured to move away from the hole 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 (such as FIG. 6A to FIG. 6C ), the plug 63 is located above the hole 56 of the cartridge seal 54 to prevent fluid from flowing through the hole 56 to the flow passage 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 apart from the hole 56 of the cartridge seal 54 to allow fluid to flow from the cartridge 12 through the hole 56 to the flow passage or flow channel 28 of the connector 26.

[0113] In some examples, the plug 63 includes a sealing portion 64 that is sized so that it moves over and covers the hole 56 to prevent fluid from flowing through the hole 56. The plug 63 also includes one or more elongated members or arms 65a, 65b extending from the sealing portion 64, which can be configured to engage or connect to a portion of the cap 24 to allow the plug 63 to rotate, as shown by arrow A5 (at Figure 6C and Figure 7C For example, Figure 5A and Figure 5BAs shown, the plug 63 includes a first arm 65a and a second arm 65b, the first arm extending from the sealing portion 64 in a first direction, and the second arm extending from the sealing portion 64 in a second direction. The arms 65a, 65b of the plug 63 may include free ends 67a, 67b, which may contact the inner surface of the cap 24 and / or may be pivotally connected to the inner surface of the cap. Due to the engagement between one or both of the free ends 67a, 67b and the cap 24, the movement of the cap 24 causes the plug 63 to move to expose the hole 56 of the cartridge seal 54.

[0114] In some examples, cap 24 may include structures, such as protrusions 68, ribs, slots, notches, gaps, or other structures, for contacting plug 63 and transmitting movement of the cap to plug 63. Figure 4B , Figure 6C and Figure 7C As shown, the cap 24 includes a pair of protrusions 68. The free end 67a of the first arm 65a is positioned between these protrusions 68 so that rotation of the cap 24 is transmitted to the plug 63, which causes the plug 63 to move away from the hole 56 when the cap 24 moves from the closed position to the open position. The plug 63 can also include a post 70 or pivot point that is received in a hole 71 on the distal surface 66 of the barrel seal 54. The plug 63 is configured to rotate about the post 70 or pivot point (as shown in FIG. Figure 5B This rotation causes the sealing portion 64 of the plug 63 to move toward or away from the hole 56 (as shown by arrow A3 in FIG. 5 ).

[0115] Continue to refer Figure 5A and Figure 5B , the plug 63 can be formed by separate parts bonded together to form the plug 63. For example, the plug 63 can include an elastomeric seal 72 located on the sealing portion 64 of the plug 63, which is configured to be positioned above the 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 by an elastomeric material, such as silicone, polypropylene, polyethylene, isoprene or natural rubber. The plug 63 also includes a body 73, which can include a more rigid material, such as a rigid thermoplastic material, for supporting the elastomeric seal 72. In particular, the body 73 is expected to be rigid enough to rotate and move toward or away from the hole 56 of the barrel seal 54 when the cap 24 moves or rotates.

[0116] refer to Figure 1A and Figure 1B as well as Figure 4A and Figure 4B, the syringe 10 also includes a cap 24 that is connected to the distal end 16 of the barrel 12 and is received in the barrel seal 54. For example, as described in further detail herein, the barrel 12 may include a locking structure (e.g., a slot, a groove, a detection member, a protrusion, a ridge, or the like) 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 that defines a flow path or flow channel 28 that 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. As used herein, a "Luer connector" refers to a connector that includes a tapered portion (i.e., a Luer taper) to form 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 tapered connector 26. For example, the connector 26 can be a tapered elongated structure, wherein 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 fluid port, a valve, or another end passage portion of the VAD including a female Luer connector. For example, a common type of fluid port of the VAD is a pierceable septum or a pre-slit septum made of rubber or other elastomeric material, which allows the insertion of a blunt elongated member or a truncated conical end (e.g., the distal end 32 of the connector 26) to infuse fluid or extract fluid from the catheter of the VAD. The size of the connector 26 of the present disclosure can be set so that the connector 26 is inserted through the septum of the VAD to establish fluid communication between the barrel 12 and the VAD through the connector 26.

[0117] In some examples, the cap 24 also includes a shield 74 extending around the connector 26. The shield 74 can be an annular or tubular structure having a proximal end and an open distal end, the proximal end is connected to the proximal end of the connector 56, and the open distal end surrounds or surrounds the connector 26. The shield 74 includes an inner surface having threads 78, which are configured to engage with the threads of the female connector to fix the syringe 10 and the cap 24 to the female connector. As previously described, the threads 78 of the shield 74 can be configured to match a female connector having a different thread arrangement, such as a female connector having threads as follows: the width at the crest of each thread is about 0.3 mm to about 1.0 mm, and the width at the bottom of the thread is about 0.5 mm to about 1.2 mm.

[0118] 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 ( Figure 1A 24 is moved from the closed position to the open position. The threads 78 on the inner surface of the shield 74 can be arranged so that the cap 24 and the syringe 10 rotate in the opposite direction or the second direction (as shown by the arrow A1 in FIG. Figure 1A ), so as to secure the cap 24 and the syringe 10 to the female connector to discharge the fluid from the syringe 10 to the VAD.

[0119] Continue to refer Figure 1A and Figure 1B as well as FIG. 2A to FIG. 2C The 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 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 84 and the distal end 86. 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.

[0120] As previously described, the cap 24 is configured to be manually manipulated by a practitioner to move the cap 24 from a closed position to an open position. To allow for such manual manipulation, in some examples, the extension 80 includes one or more slots 88 or openings extending through the sidewall 86 of the extension 80. The cap 24 may include a beam or protrusion 92 extending through the slot 88 of the extension 80 to allow the cap 24 to rotate relative to the syringe barrel 12. The cap 24 may also include a rotating ring 90 connected to the beam or protrusion 92 that surrounds the shield 74 of the cap 24. For example, as Figure 4A and Figure 4BAs shown, the cap 24 includes two protrusions 92 or beams extending from opposite sides of the shield 74. The rotating ring 90 is attached to the protrusions 92 and surrounds the shield 74. When manipulating the cap 24 to move the cap 24 from the closed position to the open position, the practitioner can grab any part of the rotating ring 90. In some examples, the rotating ring 90 may include a grasping portion (e.g., a ridge 94) to make the ring 90 easier to grasp and manipulate. In particular, the rotating ring 90 can be configured so that the practitioner can grasp the ring 90 between the thumb and the index finger to rotate the cap 24. As previously described, the rotation of the cap 24 causes the protrusion 92 or beam to slide through the slot 88, which rotates the cap 24 relative to the barrel 12. In addition, the rotation of the cap 24 actuates the stopper 63, thereby moving the stopper 63 away from the hole 56, so that the fluid can flow through the cap 24 from the barrel 12 of the syringe 10.

[0121] In some examples, the slot 88 may include an axial portion or segment extending 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 92 or beam protruding through the slot 88. The slot 88 also includes a circumferential portion or segment to allow the cap 24 to rotate relative to the barrel 12 between the first position and the second position.

[0122] Reference again FIG. 2A to FIG. 2C In some examples, the slot 88 of the barrel 12 may include a nub 77 or protrusion that protrudes from the generally flat surface of the slot 88. The nub 77 may be positioned in the slot 88 to limit or prevent the protrusion 92 or the cross beam from easily sliding through the slot 88. In some examples, the nub 77 may be positioned to effectively lock the cap 24 in the extension 80 to prevent the protrusion 92 or the cross beam from sliding through the axial section of the slot 88 and removing the cap 24 from the extension 80.

[0123] Specific reference Figure 2C The inner surface of the extension portion 80 may include a structure for fixing the barrel seal 54 disposed at the proximal end of the extension portion 80 in a suitable position. Figure 2C As shown, the extension portion 80 may include protrusions, such as axially extending ridges 96, ribs, posts, or the like, on the inner surface of the extension portion 80 to limit rotation of the barrel seal 54 positioned over the distal opening 18 of the barrel 12. Figure 3A and Figure 3BAs shown, the cartridge 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 ridge 96 and the cutout 55 of the cartridge seal 54 maintains the cartridge seal 54 in position and, in particular, prevents rotation of the cartridge seal 54 when the cap 24 is rotated between the closed position and the open position.

[0124] like Figure 2C As shown, the extension portion 80 may also include a raised circumferential protrusion, such as a raised ridge or a locking ring 98. The locking ring 98 may be positioned to ensure that the barrel seal 54 remains seated against the distal end 16 of the barrel 12 to prevent the barrel seal 54 from being lifted away from the distal opening 18 of the barrel 12 when the cap 24 is rotated between the first position and the second position. As previously described, the distal end 16 of the barrel 12 may also include an annular groove 62 (such as Figure 2C 16 ), the annular groove receives a ridge 58 or an O-ring extending from the proximal surface of the barrel seal 54. The ridge 58 or O-ring may also help maintain the position of the barrel seal 54 within the extension 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 to prevent fluid from accumulating between the barrel seal 54 and the distal end 16 of the barrel 12.

[0125] Method for expelling fluid from a syringe having an integral cap

[0126] Figure 8 A flow chart showing the steps of using syringe 10 to discharge fluid into a VAD. Figure 8 As shown, at step 110, the practitioner first obtains a prefilled syringe 10 in which 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 closed position to ensure that the medical fluid F remains in the interior of the barrel 12 to prevent contamination of the fluid and / or fluid leakage. In this initial position or prefilled position, the stopper 38 is positioned close to the proximal end 14 of the barrel 12, and the plunger rod 40 extends proximally from the stopper 38 through the proximal end 14 of the barrel 12.

[0127] At step 112, the practitioner prepares the syringe 10 for use by, for example, removing any packaging for the syringe 10 and removing the plunger cap (if present) 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. Instead, as shown in FIG. Figure 6B As shown by arrow A4 in FIG. 8 , the fluid F is blocked by the plug 63 covering the hole 56 of the cartridge seal 54 and cannot enter the flow passage 28 of the connector 26 .

[0128] 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 the rotation ring 90 of the cap 24 between the thumb and index finger and rotate the ring 90 (e.g., Figure 1A This causes the crossbar or protrusion 92 of the cap 24 to move through the slot 88 of the extension 80. When the crossbar or protrusion 92 slides through the slot 88, the cap 24 rotates from the closed position to the open position. Figure 6C and Figure 7C As shown by arrow A5 in FIG. 1 , moving the cap 24 to the open position causes the stopper 63 to rotate about the post 70 and move away from the hole 56. The movement of the stopper 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 passage or flow channel 28 of the connector 26, so that the medical fluid F can be discharged from the syringe 10.

[0129] At step 116, the practitioner then pushes the stopper 38 a short distance in the distal direction (as indicated by arrow D in FIG. 1 ) through the barrel 12, for example, by pressing 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 small distal movement of the stopper 38 removes air from the interior of the syringe barrel 12. At step 118, once any air has been 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 stopper 38 in the direction indicated by arrow A2 (as indicated by arrow D in FIG. 1 ). Figure 1A The syringe 10 and the integral cap 24 are rotated on the female connector so that the threads 78 on the inner surface of the shield 74 engage with the corresponding threads on the female connector, thereby fixing the syringe 10 and the integral cap 24 to the female connector. As previously described, the rotation direction ( Figure 1A The direction of rotation (as indicated by arrow A2 in FIG. 1 ) may be the same as the direction of rotation (as indicated by arrow A2 in FIG. 1 ) that moves the cap 24 from the closed position to the open position. Figure 1A The opposite is true (as indicated by arrow A1).

[0130] At step 120, with the cap 24 in the open position and attached to the VAD, the practitioner may use the plunger rod 40 to move the stopper 38 in the distal direction (eg, Figure 1A The plunger rod 40 is moved through the interior of the syringe barrel 12 (as indicated by arrow D in the figure) to expel the medical fluid F from the syringe barrel 12 and through the flow passage or flow channel 28 of the connector 26. For example, as previously described, the practitioner can press the thumb press 52 of the plunger rod 40 with the thumb while grasping the finger flange 36 of the syringe barrel 12 to move the plunger rod 40 in the distal direction (as shown in the figure). Figure 1A The stopper 38 moves distally through the syringe barrel 12 to force the medical fluid F to flow out of the syringe barrel 12, as shown by arrow A6 ( Figure 7B ). The practitioner continues to move the stopper 38 distally through the barrel 12 until all or substantially all of the medical fluid F is discharged from the barrel 12 through the flow passage or flow channel 28 of the connector 26 to the VAD.

[0131] At step 122, after the fluid F is expelled from the syringe barrel 12 through the connector 26, the syringe 10 can be disconnected from the VAD by: Figure 1A The syringe 10 is rotated on the housing 10 to loosen the threads 78 of the shield 74 from the corresponding threads of the female connector.

[0132] As previously described, the pre-filled syringe 10 of the present disclosure can be filled with a flushing solution and used to perform a primary flush 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 other syringes containing other medical fluids (e.g., therapeutic agents) can be connected to the female connector to provide therapeutic agents to the patient. In other examples, the pre-filled syringe 10 of the present disclosure can contain a dose of 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 therapeutic agent remaining in the VAD to the patient, thereby ensuring that a full dose of therapeutic agent is provided to the patient. This post-flush procedure can also ensure the cleanliness of the patient line by removing any debris or other contaminants on the patient line.

[0133] Although examples of the syringe 10 and method of the present disclosure including the integral cap 24 are shown in the drawings and described in detail above, other examples will be apparent to and easily made by those skilled in the art without departing from the scope and spirit of the invention. Therefore, the above 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, the cap including a connector defining a flow passage through the cap, Wherein, the cap is movable relative to the barrel between a first position and a second position, wherein in the first position, fluid is prevented from flowing through the distal opening of the barrel to the flow channel of the connector, and in the second position, 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 about the longitudinal axis of the barrel to move from the first position to the second position.

3. The syringe of claim 1 , further comprising a barrel seal positioned between the distal opening of the barrel and the cap, the barrel seal comprising at least one hole for allowing fluid to flow from the barrel to the flow passage of the connector, and in, The cartridge seal includes a disk portion positioned over the distal end of the cartridge and an annular wall portion extending from the disk portion to be positioned against an inner surface of the cartridge, wherein the at least one aperture extends through the disk portion.

4. The syringe according to claim 3, wherein: The cylinder seal comprises: an annular ridge extending proximally from a proximal surface of the disc portion, the annular ridge being received within a corresponding annular groove on the distal end of the barrel, and A lip extends radially inwardly from the annular wall portion of the cartridge seal, the lip being configured to engage the cap to retain a proximal portion of the cap within the cartridge seal.

5. The syringe of claim 3, further comprising a stopper engaged to the cap, the stopper moving as the cap moves from the first position to the second position, wherein When the cap is in the first position, the plug is located over the at least one hole of the cartridge seal to prevent fluid from flowing through the at least one hole of the cartridge seal to the flow passage 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 cartridge seal to allow fluid to flow from the cartridge through the at least one hole of the cartridge seal to the flow passage of the connector.

6. The syringe according to claim 5, wherein: The stopper includes a sealing portion that moves over the at least one aperture of the cartridge seal and at least one arm extending from the sealing portion, the at least one arm being engaged to a portion 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 an inner surface of the cap such that the plug is movable to expose the at least one aperture of the cartridge seal when the cap is moved from the first position to the second position.

8. The syringe according to claim 5, wherein: The cap includes at least one pair of protrusions extending radially inward from an inner surface of the cap, and wherein an end of the at least one arm of the plug is positioned between the pair of protrusions such that the protrusions move the plug when the cap is rotated from the first position to the second position.

9. The syringe according to claim 5, wherein: The stopper includes an elastomeric seal configured to be positioned over the at least one aperture of the cartridge seal to seal the at least one aperture of the cartridge seal when the cap is in the first position.

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

11. The syringe according to 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 to secure 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, and wherein the cap is connected to and at least partially surrounded by the extension, and Wherein, the cap includes at least one protrusion, and the at least one protrusion extends radially outward from the shield to enable the cap to rotate relative to the barrel.

13. The syringe according to claim 12, wherein: The cap further includes a rotating ring including the at least one protrusion, wherein the rotating ring extends around the shield of the cap and the extended portion of the barrel, and Wherein, 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 portion includes 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.

15. The syringe according to claim 14, wherein The at least one slot includes at least one tab protruding from a surface of the slot, the at least one tab restricting the at least one protrusion from sliding through the slot to lock the cap in the extension portion.

16. The syringe according to claim 12, wherein: The extension portion further includes a protrusion on an inner surface of the extension portion for limiting rotation of a barrel seal positioned over the distal opening of the barrel, and Wherein, the protrusion comprises an axially extending ridge, rib or post located on the inner surface of the extension portion.

17. A pre-filled flushing syringe, the pre-filled 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 located in the first position, thereby preventing the fluid in the barrel from passing through the open distal end portion of the barrel to reach the flow channel of the connector.

18. The prefilled syringe of claim 17, wherein: The fluid includes a saline flush solution or a therapeutic agent.

19. 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.

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 relative to the longitudinal axis of the syringe.

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