Rinsing syringe with a flip cap

Abstract

This document describes a flushing syringe assembly. Such a flushing syringe assembly may include a barrel, a ferrule mounted on the distal sidewall of the barrel and surrounding an elongate tip, wherein the barrel includes sidewalls defining a chamber. A cap may be attached to the ferrule via a hinge. The flushing syringe assembly may also include a cap attached to the ferrule via a hinge. A ring may be provided around the ferrule and have locking elements that engage corresponding mating locking protrusions on the cap. The cap may include an inclined surface. The inclined surface of the cap may include one or more ribs made of an elastic material.

Description

[0001] Division Explanation

[0002] This invention patent application is a divisional patent application.

[0003] The original application of this divisional patent application (i.e., the parent case, firm file number IIM201659) is an invention patent application with an international filing date of January 25, 2019, an international application number of PCT / US2019 / 015100, a Chinese national application number of 201980007879.3, and an invention title of "Flush Syringe with Flip Cap". Technical Field

[0004] Generally speaking, the present disclosure relates to syringe assemblies. Specifically, the present disclosure relates to syringe assemblies including a physical barrier to prevent contact of the syringe tip with the surrounding non-sterile environment. Embodiments of the present disclosure ensure compliance with aseptic techniques in flushing procedures for vascular access devices (VADs). Embodiments of the present disclosure also relate to techniques for reducing the risk of catheter-related bloodstream infections (CRBSIs) and maintaining the patency of intravenous (IV) lines, including capping techniques, particularly for syringe assemblies, to allow for single-handed removal of the syringe cap during flushing procedures. Background Art

[0005] Vascular access devices (VADs) are commonly used therapeutic devices, which include peripheral catheters and central venous catheters. If not properly maintained or if exposed to a non-sterile environment, VADs can become contaminated, sealed with blood clots, or transmit infections. To ensure that VADs are used correctly and are not sealed or infected, some protocols for ensuring sterilization practices have been developed. These protocols include sterilizing the VAD and flushing the catheter with a flushing solution. Syringe assemblies filled with various fluids are used to flush the catheter. In some cases, different fluids are injected sequentially according to the protocol. For example, a saline solution, and then an anticoagulant (such as heparin). The size of the syringe used to flush an intravenous (I.V.) line varies depending on various factors, including the size and length of the catheter. Syringes with capacities of 1 ml, 3 ml, 5 ml, and 10 ml are commonly used. VAD protocols generally recommend flushing procedures after catheter placement, before fluid infusion, and before and after drug administration, blood sampling, blood transfusion, and parenteral nutrition. The purpose of these flushing procedures is to confirm the patency of the catheter, avoid drug incompatibility, ensure complete administration of the drug dose, prevent thrombosis, and minimize the risk of bloodstream infections.

[0006] Currently available prefilled syringes have a syringe tip cap that requires two hands to hold the syringe and remove the cap. Conventional flushing syringes have a barrel with a Luer tip at one end, and once the syringe tip is removed from the packaging, the barrel is exposed to a non-sterile environment, providing an opportunity for undesirable contamination. Accordingly, there is a need for a syringe, particularly a flushing syringe, that provides a physical barrier around the syringe tip to improve aseptic practice by reducing or eliminating "contact" contamination of the syringe (particularly the syringe tip) with the surrounding non-sterile environment. There is also a need for a syringe, particularly a flushing syringe, that allows a clinician to open the protective cap with one hand without having a hand near the syringe tip. In addition to enhancing safety, this single-handed operation will significantly improve workflow and efficiency. Summary of the Invention

[0007] One aspect of the present disclosure relates to a flushing syringe assembly that includes a barrel having a sidewall, an open proximal end, and a distal end. The inner surface of the sidewall defines a chamber for holding fluid. The distal end includes a distal sidewall having an elongate tip extending distally therefrom. The elongate tip has a passage therethrough that is in fluid communication with the chamber. A ferrule may be mounted on the distal sidewall of the barrel and surround the elongate tip. The ferrule includes at least one sidewall, an open distal end, and a proximal end adjacent to the distal sidewall of the barrel, wherein the at least one sidewall has an inner surface that defines a compartment. A cap may be attached to the ferrule via a hinge. An elongate plunger rod is disposed within the barrel. The plunger rod includes a distal end and a proximal end. The distal end includes a stopper that is slidably positioned in fluid-tight engagement with the inner surface of the barrel for drawing fluid into the chamber and expelling fluid from the chamber by movement of the stopper relative to the barrel. The elongate plunger rod extends outwardly from the open proximal end of the barrel, and the stopper has a distal surface.

[0008] In one or more embodiments, the compartment of the ferrule surrounds the elongate tip.

[0009] In one or more embodiments, the hinge is a living hinge.

[0010] In one or more alternative embodiments, the hinge is butterfly-shaped and has a central hinge section and two wings.

[0011] In one or more alternative embodiments, the hinge is spring-loaded.

[0012] In one or more alternative embodiments, the hinge opens between a fully closed position and a fully open position of at least 120 degrees.

[0013] In one or more alternative embodiments, the cap includes an outwardly extending protrusion that interacts with the elongate tip.

[0014] In one or more embodiments, the protrusion may be button-shaped, pin-shaped, or umbrella-shaped.

[0015] In one or more embodiments, a washer may be disposed between the ferrule and the cap.

[0016] In one or more embodiments, the locking element is in the form of an arm.

[0017] In one or more embodiments, the cap includes an inclined surface. In one or more embodiments, the inclined surface may include one or more ribs. The one or more ribs may be made of an elastomeric material.

[0018] Another aspect of the present invention relates to a flushing syringe assembly that includes a barrel having a sidewall, an open proximal end, and a distal end. The inner surface of the sidewall defines a chamber for holding fluid. The distal end includes a distal sidewall having an elongate tip extending distally therefrom. The elongate tip has a passage therethrough that is in fluid communication with the chamber. A ferrule may be mounted on the distal sidewall of the barrel and surround the elongate tip. The ferrule includes at least one sidewall, an open distal end, and a proximal end adjacent to the distal sidewall of the barrel. The inner surface of the at least one sidewall defines a compartment. In one or more embodiments, a cap may be attached to the ferrule via a hinge. In one or more embodiments, a ring is disposed around the ferrule having a locking element that engages a corresponding mating locking protrusion on the cap. In one or more embodiments, an elongate plunger rod is disposed within the barrel. The plunger rod includes a distal end and a proximal end. The distal end includes a stopper that is slidably positioned to engage the inner surface of the barrel in a fluid-tight manner for drawing fluid into the chamber and expelling fluid from the chamber by movement of the stopper relative to the barrel. The elongate plunger rod extends outwardly from the open proximal end of the barrel.

[0019] In one or more embodiments, the ring may be rotated to disengage the locking element from the mating locking protrusion on the cap. In one or more embodiments, the ring includes one or more thumb supports. In one or more embodiments, the locking element is in the form of an arm.

[0020] In one or more embodiments, the cap includes an inclined surface. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 A perspective view of a flushing syringe in accordance with one or more embodiments of the present disclosure is shown with the flip cap and locking element in an open position;

[0022] Figure 2 A perspective view of a flushing syringe in accordance with one or more embodiments of the present disclosure is shown with the flip cap and locking element in an open position;

[0023] Figure 3 A perspective view of a ring having a locking element and a rotating tab in accordance with one or more embodiments of the present disclosure is shown;

[0024] Figure 4 shows a side view of a ring according to one or more embodiments of the present disclosure Figure 3 ;

[0025] Figure 5 shows a top view of a ring according to one or more embodiments of the present disclosure Figure 3 ;

[0026] Figure 6 shows a partial perspective view of a flush syringe having a hinge with a connecting ferrule and a cap according to one or more embodiments of the present disclosure

[0027] Figure 7 shows a cross-sectional perspective view of a flush syringe having a ferrule and a cap according to one or more embodiments of the present disclosure

[0028] Figure 8 shows a partial perspective view of a ferrule and a cap having a button-shaped sealing protrusion and a locking element according to one or more embodiments of the present disclosure

[0029] Figure 9 shows a side view of a syringe assembly having a ferrule, a ring, and a cap in an open position according to one or more embodiments of the present disclosure

[0030] Figure 10 shows a top view of a syringe assembly having a ferrule, a ring, and a cap in an open position according to one or more embodiments of the present disclosure

[0031] Figure 11 shows a partial perspective view of a flush syringe having a ferrule, a hinge, and a cap according to one or more embodiments of the present disclosure

[0032] Figure 12 shows a perspective view of a flush syringe having a ferrule and a cap in an open position and no ring according to one or more embodiments of the present disclosure

[0033] Figure 13 shows a perspective view of a flush syringe having a ferrule and a cap in an open position and having a ring according to one or more embodiments of the present disclosure

[0034] Figure 14 shows a top view of a flush syringe having a ferrule, a ring, and a cap in a closed position according to one or more embodiments of the present disclosure

[0035] Figure 15Shows a rear view of a flush syringe according to one or more embodiments of the present disclosure, the flush syringe having a ferrule, a ring, and a cap in a closed position.

[0036] Figure 16 Shows a perspective view of a flush syringe according to one or more embodiments of the present disclosure, the flush syringe having a ferrule, a ring, and a cap in a closed position.

[0037] Figure 17A Shows a top view of a cap having a butterfly hinge according to one or more embodiments of the present disclosure.

[0038] Figure 17B Shows an exploded side view of a syringe assembly having a butterfly hinge according to one or more embodiments of the present disclosure.

[0039] Figure 17C Shows a perspective view of the interior of a cap having a protrusion and a butterfly hinge according to one or more embodiments of the present disclosure.

[0040] Figure 17D Shows a rear view of a syringe assembly having a butterfly hinge according to one or more embodiments of the present disclosure.

[0041] Figure 18A Shows a view of a cap of a syringe assembly according to one or more embodiments of the present disclosure, the cap having a projection in the shape of an umbrella pin that plugs the elongated tip.

[0042] Figure 18B Shows according to one or more embodiments of the present disclosure Figure 18A A partial view of the projection in the shape of an umbrella pin shown in, which plugs the elongated tip.

[0043] Figure 19A Shows a side view of a flush syringe having a spring-loaded hinge according to one or more embodiments of the present disclosure.

[0044] Figure 19B Shows according to one or more embodiments of the present disclosure as Figure 19A A perspective view of the spring-loaded hinge shown.

[0045] Figure 20A Shows a front view of a cap according to one or more embodiments of the present disclosure, which shows a groove feature inside the cap that provides a seal when closed and engages a sealing ring on the outer surface of the barrel ferrule.

[0046] Figure 20BA side view of a cap according to one or more embodiments of the present disclosure is shown, which shows a groove feature inside the cap that provides a seal when closed and engages a sealing ring on the outer surface of the barrel ferrule.

[0047] Figure 21 A perspective view of a flush syringe according to one or more embodiments of the present disclosure is shown, the flush syringe having a ferrule and a cap in a closed position.

[0048] Figure 22 A perspective view of a flush syringe according to one or more embodiments of the present disclosure is shown, the flush syringe having a ferrule and a cap in an open position.

[0049] Figure 23 A perspective view of a flush syringe attached to a vascular access device according to one or more embodiments of the present disclosure is shown, the flush syringe having a ferrule and a cap in an open position.

[0050] Figure 24 A perspective view of a flush syringe in use according to one or more embodiments of the present disclosure is shown, the flush syringe having a ferrule and a cap. Detailed Description

[0051] Before describing several illustrative embodiments of the present disclosure, it should be understood that the present disclosure is not limited to the details of the construction or process steps set forth in the following description. The present disclosure is capable of other embodiments and of being practiced or carried out in various ways.

[0052] The following definitions are provided with respect to the terms used in the present disclosure.

[0053] Reference to a "flush syringe assembly" includes a syringe for VAD flushing. The practice of flushing ensures and maintains catheter patency and helps prevent mixing of incompatible drugs.

[0054] As used herein, the use of "a" and "the" includes the singular and the plural.

[0055] The term "catheter-related bloodstream infection" or "CRBSI" as used herein refers to any infection caused by the presence of a catheter or venous line.

[0056] As used herein, the term "Luer connector" refers to a connecting ferrule, which is the standard way to attach syringes, catheters, hubbed needles, intravenous tubing, etc. to each other. A Luer connector consists of a male and a female interlocking tube, slightly tapered, which hold together better even with just a simple press / twist fit. Luer connectors may optionally include an additional threaded outer rim to make them more secure. The male end of the Luer connector is typically associated with a flush syringe and can interlock and connect with the female end located on the VAD. The Luer connector includes a distal end, a proximal end, an irregularly shaped outer wall, a molded central passage for fluid communication from the chamber of the barrel of the syringe to the hub of the VAD. The Luer connector also has a distal passage for releasably attaching the Luer connector to the hub of the VAD and a proximal passage for releasably attaching the Luer connector to the barrel of the syringe.

[0057] Clinicians need to handle multiple components when accessing an intravenous (IV) line or catheter: opening the hub and disinfecting it, opening the syringe, holding the line in place, etc., while ensuring that no device touches any surface, as this will cause contamination and bloodstream infections, which can have fatal consequences. Thus, accessing an intravenous (IV) line or catheter is not simple and requires a degree of dexterity to perform the procedure while preventing the syringe tip from contacting the surrounding environment. If the syringe tip touches any non-sterile surface, "contact" contamination occurs, which can lead to microbial growth in the IV line and thus to events of catheter-related bloodstream infection ("CRBSI") and central line-associated bloodstream infection ("CLABSI"), which are costly and fatal.

[0058] Embodiments of the present disclosure relate to a flush syringe having a ferrule and a hinged cap around the elongated tip of the syringe. The ferrule provides a physical barrier around the syringe tip. Due to its shape, the ferrule of the present disclosure helps to align the flush syringe with the catheter hub and / or needleless connector, thereby reducing the chance of "contact" contamination. Embodiments of the present disclosure protect the syringe tip, while currently available syringes expose the syringe tip completely once the protective tip cap is removed, thus making the syringe tip vulnerable to contact contamination. Embodiments of the present disclosure have an integrated raised ferrule around the syringe tip, making it easy to align Luer tips (which can be very small) in devices such as needleless connectors and pre-filled syringes, while also allowing prevention of contact contamination. Without embodiments of the present disclosure, alignment of the Luer tip requires careful attention and visual precision in order to be able to perfectly align the two parts so that no contamination occurs.

[0059] Reference Figures 1-13, the syringe assembly 10 according to the present disclosure generally includes a barrel 20. The barrel 20 includes a sidewall 21, and the inner surface of the sidewall 21 defines a chamber 22 for holding a fluid. In one or more embodiments, the fluid is a flushing fluid. The barrel 20 also includes an open proximal end and a distal end, and the distal end has a distal sidewall with an elongate tip 23 that extends distally from the distal sidewall and has a passage 24 therethrough that is in fluid communication with the chamber. The distal sidewall is adapted to be connected to a ferrule 30.

[0060] As Figure 2 shown, the ferrule 30 is mounted at the distal end of the barrel 20. The ferrule 30 includes at least one sidewall 31, an open distal end 32, and a proximal end 33 adjacent to the distal sidewall 25 of the barrel. The inner surface of the at least one sidewall 31 defines a compartment surrounding the elongate tip 23. The elongate tip 23 is adapted to be connected to a hub of a vascular access device. As Figure 2 shown, the inner surface of the cap 40 has a protrusion in the form of a button for plugging a corresponding Luer tip to prevent fluid leakage in the cap region when closed.

[0061] In one or more embodiments, the ferrule 30 is a raised ferrule surrounding the elongate tip 23. In one or more embodiments, the ferrule 30 is an extension of the sidewall 21. The ferrule 30 helps to align the elongate tip 23 with other Luer devices (such as a needleless connector) and protects the elongate tip from contact contamination.

[0062] In one or more embodiments, as Figures 3-5 and Figure 13 shown, the ferrule 30 has a ring 60 around the ferrule 30, and the ring 60 has a locking element 70 that can engage a corresponding mating locking protrusion 71 on the cap 40. The ring 60 is rotated to disengage the locking element 70 from the corresponding mating locking protrusion 71 on the cap 40 to prepare to flip the cap open. In one or more embodiments, there are two thumb supports 80 for rotating the ring 60, one for a left-handed clinician and the other for a right-handed clinician.

[0063] In one or more embodiments, the structure for automatically locking the cap 40 in the tip protection position includes at least one locking element 70 protruding from the outer surface of the ring. In one or more embodiments, the locking element 70 can be in the form of an arm. The arm includes a free end that is positioned such that when the cap 40 is pivoted to the closed position, the free end of the arm engages a corresponding mating locking protrusion 71 on the outer surface of the ferrule. As Figure 2As shown, the ring 60 may include a thumb-rotating handle 80 to assist in rotating the ring 60 and the locking element 70 thereon, so as to disengage the free end of the arm of the locking element 70 from the corresponding mating locking protrusion 71 on the outer surface of the ferrule.

[0064] In one or more embodiments, as Figure 8 shown, an inclined surface 90 is provided on the top surface of the cap 40, and the inclined surface 90 has one or more ribs 92, which can improve the grip. The inner surface of the cap 40 has an outwardly extending protrusion 100, and the protrusion 100 seals the Luer tip and prevents leakage when the cap is closed. In one or more embodiments, the protrusion 100 may be in the shape of a pin or a button, as Figures 6-8 shown.

[0065] In one or more embodiments, the cap 40 is attached to the ferrule 30 via a hinge 50. Figure 6 A partial perspective view of a flushing syringe according to one or more embodiments of the present disclosure is shown, and the flushing syringe has a hinge 50 connecting the ferrule 30 and the cap 40. In one or more embodiments, the hinge is a movable hinge. In one or more embodiments, the cap 40 is a flip-open cap. In one or more embodiments, the cap 40 includes a side wall and a top wall, the side wall defines a longitudinal opening, and the top wall defines a recess having an inner surface between the side walls. The cap can pivot from an open position to a closed protection position. In the open position, the elongated tip 23 is exposed, and in the closed protection position, the distal end of the elongated tip 23 is located within the longitudinal opening of the cap. In one or more embodiments, the ferrule 30 and the cap 40 may be molded together and then assembled with the barrel 20. In an alternative embodiment, the ferrule 30 and the syringe barrel 20 are molded together, and the cap 40 is attached to the assembly.

[0066] The outwardly extending protrusion 100 prevents leakage after the syringe is filled, and the cap 40 is closed until the cap 40 is opened just before use. In one or more embodiments, the outwardly extending protrusion or pin may be oriented, configured, and / or shaped to allow the protrusion to enter the opening at the distal end of the elongated tip, as Figures 11-13 shown.

[0067] As Figure 14 shown, in one or more embodiments, the thumb-rotating handle 80 may include two or more thumb supports (81, 82) for rotating the ring. In Figure 14 the illustrated embodiment shown, the thumb support 81 is configured for right-handed clinicians, while the thumb support 82 is configured for left-handed clinicians.

[0068] The function of the hinge 50 is that once the hinge 50 is opened, it remains in place. In one or more embodiments, asFigures 17A to 17D As shown, the hinge 50 has a butterfly shape and has: a central section that serves as the hinge; and two wings on both sides to snap it into place. In one or more embodiments, the side profile of the central section is triangular.

[0069] The inner surface of the cap 40 has an outwardly extending protrusion 100 that seals the Luer tip and prevents leakage when the cap is closed. In one or more alternative embodiments, as Figure 18A shown, the outwardly extending protrusion 100 can be shaped like a small umbrella, whereby the protrusion 100 forms an arch on the outside of the top part of the distal end of the elongated tip. As Figure 18B shown, the central part of the outwardly extending protrusion 100 is flat and contacts the inner part of the top surface of the corresponding syringe tip, while the outer edge is flared or curved downward to enclose the top surface of the corresponding syringe tip, and the top surface of the corresponding syringe tip can have a stepped curvature. Figure 18A and 18B shown, one or more embodiments of the cap 40 can include an umbrella pin-shaped protrusion 100 that seals the elongated tip.

[0070] As Figure 19A and 19B shown, in one or more embodiments, the hinge 50 can also be spring-loaded, where the pre-tension of the spring 55 is adjusted such that: once the cap 40 pops open, the hinge 50 opens to the desired extent. In one or more embodiments, the hinge combines with a spring element to form a hinge assembly. In one or more embodiments, the spring element can include a first section and a second section that are aligned or compressed relative to each other in the initial closed cap state. However, the first section and the second section of the spring element can be elastically deflected due to the inherent elasticity in the spring element to push the cap to the open position. The self-propelling property of the combination of the hinge and the spring element facilitates the one-handed operation of the needle. The accumulated energy of the spring does work for the user by pushing the cap to the open position to expose the elongated tip. When in the open position, the spring element 55 will preferably be in a stable state, preferably having little or no stored energy. The hinge 50 operated or loaded by the spring 55 allows the cap to be opened to an angle greater than 120°.

[0071] In one or more embodiments, the hinge 50 opens to the desired extent of at least 120 degrees between the fully closed position and the fully open position.

[0072] As Figure 20A and 20B shown, other embodiments can additionally include a washer feature between the ferrule and the flipped-open cap to form a tight seal for maintaining sterility. In one or more embodiments, the elongated tip can be a Luer tip.

[0073] As Figure 20A and 20B shown, other embodiments may additionally include a washer feature between the ferrule and the opened cap to form a tight seal for maintaining sterility. In one or more embodiments, the elongated tip may be a Luer tip.

[0074] As Figure 20A and 20B shown, in one or more embodiments, the cap is opened in two steps. In the first step, by the user pushing upward on "Surface A" with the thumb, the cap is pushed upward to disengage from the ring and groove features. In the second step, by pushing upward on "Surface A" with the thumb, the cap is flipped backward from its initial position. In one or more embodiments, there is no need to reposition the thumb.

[0075] In one or more embodiments, Surface A has a surface texture to enhance friction with the user's thumb. In one or more embodiments, as Figure 20B shown, a finger grip 110 may be incorporated on the outer surface of the cap. In one or more embodiments, the finger grip 110 may be made of a suitable elastomer.

[0076] In one or more embodiments, the cap 40 is easily opened by flipping the cap backward (the user's thumb moves away from the elongated tip 23), and the cap is also tight enough to provide a minimum level of sterility assurance. The two-step opening process allows the user to disengage the tight seal in one step and permits easy removal of the cap, as the cap is designed to prevent the need to reposition the user's thumb between the two steps.

[0077] In one or more alternative embodiments, as Figure 20A shown, the cap 40 may have more than one ring-groove set feature (e.g., two consecutive rings). As Figure 20A shown, a groove 42 is provided on the inner side of the cap, which provides a seal when closed and engaged with a sealing ring 44 on the outer surface of the barrel ferrule.

[0078] In one or more embodiments, as Figure 21 shown, a skirt 150 may extend vertically from the top surface of the cap 40 and is sized to sealingly engage with the ferrule.

[0079] The syringe, cap, and ferrule may be made of suitable medical-grade materials, including polymers or metals. Preferably, the cap is injection molded using a thermoplastic material and / or thermoplastic elastomer (TPE).

[0080] In one or more embodiments, the shape of ferrule 30 can vary. Ferrule 30 can have the following shapes, including but not limited to: circular, oval, convex inner surface (such as parabolic), concave inner surface, with a straight profile (i.e., semi-conical), or having the shape of a trapezoidal prism. The length and the openness / flatness of the profile of this extension from the syringe body (how wide the ferrule is at the end furthest from the syringe barrel) can vary.

[0081] In one or more embodiments, ferrule 30 surrounds elongate tip 23, which is adapted to connect to the hub of a vascular access device. In one or more embodiments, the elongate tip is a Luer tip.

[0082] Cap 40 can include an outward protrusion 100 extending from the body of cap 40 and corresponding to the distal opening of elongate tip 26.

[0083] The cross-sectional shape of cap 40 can be any suitable shape, including but not limited to circular, oval, triangular, square, pentagonal, hexagonal, heptagonal, octagonal, symmetric or asymmetric polygon. The shape of cap 40 can provide a comfortable feel and enhanced gripping ability for the user to allow the user to easily open the cap from locking element 70 and the corresponding mating locking protrusion 71.

[0084] Known methods can be used to fill syringe assembly 10 with a flush solution. Additionally, syringe assembly 10 can be pre-filled by the manufacturer or supplier. The flush solution can be any solution intended to flush or maintain VAD performance. Preferably, the flush solution is selected from saline flush solutions and heparin lock flush solutions. These solutions are known in the art and readily available. Examples of saline flush solutions include but are not limited to 0.9% sodium chloride injection. Examples of heparin lock flush solutions include but are not limited to 0.9% sodium chloride with 100 USP units of sodium heparin per milliliter or 10 USP units of sodium heparin per milliliter.

[0085] Once the connection of syringe assembly 10 to the VAD is complete, fluid communication can occur from barrel 20 of the syringe to the vascular access device. Fluid is drawn from barrel 20 through integral passageway 27 into the IV or catheter. Due to the presence of ferrule 30, fluid communication through the vascular access device and into the patient occurs under sterile conditions without any additional wiping steps and effort by the clinician.

[0086] In one or more embodiments, ferrule 30 can be integrally formed on the distal sidewall 25 of syringe barrel 20 for fluid communication with the vascular access device.

[0087] The barrel may also include a tip 23 extending distally from the barrel. The outer diameter of the tip may be different from or equal to the outer diameter of the remainder of the barrel. For example, as shown, the outer diameter of the tip is smaller than the outer diameter of the barrel portion proximal to the tip. The tip of the barrel may include a locking Luer-type or ferrule Luer slip connection concentrically around or within the tip.

[0088] As Figure 21 shown, the elongate plunger rod 120 may include a distal portion and a proximal portion, the plunger rod further including a distal end that includes a stopper 130 that is slidably positioned in fluid-tight engagement with the inner surface of the barrel for drawing fluid into the chamber and expelling fluid from the chamber by movement of the stopper relative to the barrel, the elongate plunger rod extending outwardly from the open proximal end 28 of the barrel 20, the stopper having a distal surface.

[0089] The elongate plunger rod may be disposed within the barrel 20. The plunger rod 120 includes an elongate body portion having a proximal end and a distal end.

[0090] The elongate body portion of the plunger rod has an axial length extending from the proximal end to the distal end. The body portion may include a single beam or feature, which may have a cylindrical or other shape. The body portion may be formed by two perpendicularly intersecting beams.

[0091] The plunger rod may also include a thumb press 140 at the proximal end of the elongate body portion. The shape of the thumb press may vary depending on the desired use of the irrigation syringe assembly. The shape of the thumb press may be circular, square, rectangular, triangular, oval, pentagonal, hexagonal, and cross-shaped.

[0092] The stopper 130 may be connected to the distal end of the plunger rod. The shape and size of the stopper may be any suitable shape or size, depending on, for example, the shape and size of the barrel and the plunger rod. The plunger rod is slidably positioned within the barrel such that the stopper is in fluid-tight contact with the inner surface of the barrel and such that distal movement of the plunger rod relative to the barrel causes the stopper to expel fluid from the barrel. In some embodiments, the stopper is slidably positioned in fluid-tight contact with the inner surface of the barrel for expelling fluid from the chamber by movement of the stopper relative to the barrel. The stopper may be connected to the distal end of the elongate plunger rod by any suitable means. In some embodiments, the stopper is connected by a mechanical connection, such as the interaction of complementary threads and a press-fit connection. The stopper may be slidably positioned in fluid-tight engagement with the inner surface of the barrel for drawing fluid into the chamber and expelling fluid from the chamber.

[0093] The plug can be made of any material suitable for providing a seal with the inner surface of the barrel. For example, the plug can be made of a thermoplastic elastomer, natural rubber, synthetic rubber, or a thermoplastic material, and various combinations of the above options. The plug can be integrally formed or consist of separate components of the same or different materials joined together. The plunger rod can be made of a material that is more rigid than the plug, such as polypropylene, polyethylene, etc. Materials compatible with the procedures used should be selected.

[0094] Figure 21 A perspective view of a flush syringe according to one or more embodiments of the present disclosure is shown, the flush syringe having a ferrule and a cap in a closed position. As Figure 21 shown, a syringe assembly including a plunger rod and a syringe barrel is also provided, the syringe barrel having an open proximal end and a distal tip, the distal syringe tip being surrounded by a ferrule to facilitate alignment of the syringe with a catheter hub or a needleless connector, and to reduce contamination of the syringe by preventing the syringe tip from contacting the surrounding non-sterile environment.

[0095] Figure 22 A perspective view of a flush syringe according to one or more embodiments of the present disclosure is shown, having a ferrule and a cap in an open position.

[0096] Figure 23 A perspective view of a flush syringe attached to a vascular access device 200 according to one or more embodiments of the present disclosure is shown, the flush syringe having a ferrule and a cap in an open position.

[0097] Figure 24 A perspective view of a flush syringe in use according to one or more embodiments of the present disclosure is shown, the flush syringe having a ferrule and a cap.

[0098] Although the present disclosure has been described with reference to specific embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the present disclosure. Accordingly, it should be understood that various modifications can be made to the exemplary embodiments, and other arrangements can be designed without departing from the spirit and scope of the present disclosure as disclosed.

Claims

1. A flushing syringe assembly, comprising: A barrel including a sidewall, an open proximal end, and a distal end, wherein an inner surface of the sidewall defines a chamber for holding fluid, the distal end includes a distal sidewall having an elongate tip extending distally therefrom, and the elongate tip has a passage therethrough in fluid communication with the chamber; A ferrule mounted on the distal sidewall of the barrel and surrounding the elongate tip, the ferrule including at least one sidewall, an open distal end, and a proximal end adjacent to the distal sidewall of the barrel, and an inner surface of the at least one sidewall defining a compartment; A cap attached to the ferrule via a hinge, wherein the cap includes: a protrusion extending outwardly that interacts with the elongate tip; a groove provided on an inner side of the cap for providing a seal when closed and engaging a sealing ring on an outer surface of the ferrule of the barrel; and a skirt extending vertically from a top surface of the cap and sized for a sealing engagement with the ferrule; A gasket disposed between the ferrule and the cap; and An elongate plunger rod disposed within the barrel, the elongate plunger rod including a distal end and a proximal end, the distal end of the elongate plunger rod including a plug slidably positioned in fluid sealing engagement with an inner surface of the barrel for drawing fluid into the chamber and expelling fluid from the chamber by movement of the plug relative to the barrel, the elongate plunger rod extending outwardly from the open proximal end of the barrel, and the plug having a distal surface.

2. The flushing syringe assembly according to claim 1, wherein, The compartment of the ferrule surrounds the elongate tip.

3. The flushing syringe assembly according to claim 1, wherein, The hinge is a living hinge.

4. The flushing syringe assembly according to claim 1, wherein, The hinge is butterfly-shaped, having a central hinge section and two wings.

5. The flushing syringe assembly according to claim 1, wherein, The hinge is spring-loaded.

6. The flushing syringe assembly according to claim 5, wherein, The hinge opens between a fully closed position and a fully open position of at least 120 degrees.

7. The flushing syringe assembly according to claim 1, wherein, The protrusion has a flat central portion and an outer edge that flares or curves downward.

8. The flushing syringe assembly according to claim 1, wherein, The protrusion is button-shaped.

9. The flushing syringe assembly according to claim 1, wherein, The protrusion is pin-shaped.

10. The flushing syringe assembly according to claim 1, wherein, The protrusion is umbrella-shaped.

11. The flushing syringe assembly according to claim 1, wherein, The cap includes an inclined surface.

12. The flushing syringe assembly according to claim 11, wherein, The inclined surface includes one or more ribs.

13. The flushing syringe assembly according to claim 12, wherein, The one or more ribs are made of an elastomeric material.

14. The flushing syringe assembly according to claim 1, further comprising: A ring surrounding the ferrule, having a locking element that engages a corresponding mating locking protrusion on the cap.

15. The flushing syringe assembly according to claim 14, wherein, The ring is rotated to disengage the locking element from the mating locking protrusion on the cap.

16. The flushing syringe assembly according to claim 14, wherein, The ring includes one or more thumb supports.

17. The flushing syringe assembly according to claim 14, wherein, The locking element is shaped in the form of an arm.

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