Multiple Servicing Flush Syringe

Abstract

A flush syringe equipped with a syringe coupler facilitates two-step distribution of intravenous flushing fluid to a patient's vascular access device (VAD) with a reduced risk of VAD infection. The syringe coupler incorporates a female first Luer connector at its proximal end, which is detachably coupled to the male barrel Luer connector of the syringe, isolating the male barrel Luer connector from external contamination. The syringe coupler also has a single-use male second Luer connector at its distal end of the housing, which is fitted into a coupled insertion into the patient's VAD to deliver at least a portion of the flushing fluid held in the syringe. After the first delivery, the syringe coupler is detached from both the VAD and the syringe. The syringe's unused, sterile male barrel Luer connector is then connected directly to the VAD to deliver a second portion of the flushing fluid.

Description

Technical Field

[0001] The present disclosure generally relates to a syringe for flushing a patient's vascular access device (VAD), such as a patient access port. More specifically, the present disclosure relates to a flush syringe that distributes a flush solution to a patient's VAD in two separate flushing procedures (e.g., before and after drug administration), each using a new sterile port connector to reduce the potential risk of VAD infection.

Background Art

[0002] Background Vascular access devices (VADs) are commonly used treatment devices and include intravenous (IV) catheters. There are two general classifications of VADs: peripheral catheters and central venous catheters. When delivering fluids or medications, several types of access hubs, ports, or valves are connected to the VAD. Some IV patient ports are actuated by the frustoconical tip (such as a luer connector) of a syringe barrel to allow fluid communication between the interior of the syringe and the catheter. A luer connector is a common method for interconnecting or connecting syringes, catheters, hub needles, IV tubes, etc. When a VAD is used in the care of a medical patient, there is a potential risk of component occlusion and contamination.

[0003] If not properly maintained, VADs can become occluded. To ensure that VADs are used correctly and do not become occluded, operational standards have been developed. These standards include cleaning procedures, commonly referred to as flushing or catheter flushing. VAD operational standards typically recommend that flushing procedures be performed after catheter placement, before fluid infusion, before drug administration, blood sample collection, blood transfusion, and before and after parenteral nutrition. The purpose of these flushing procedures is to confirm catheter patency, avoid drug incompatibility, ensure complete drug equivalent delivery, prevent thrombus formation, and minimize the risk of bloodstream infection. Flushing procedures require various types and amounts of flushing fluid. Commonly used flushing fluids are saline and / or heparin-locked solutions. The type and amount of flushing fluid vary depending on the specific type of catheter. While 5-10 ml of flushing fluid is most common, it can range from 1 ml to 20 ml.

[0004] Flushing is also performed after drug administration because residual drug may remain in the Luer portion of the drug administration syringe and within the catheter. Without the subsequent flushing procedure, the entire drug dose may not be delivered to the patient. Some drugs are administration time sensitive and should not remain in the catheter until the next drug administration flushes away any residual drug from the previous drug through the line. Therefore, to address the issue of drug residue administration, sequential flushing is performed with a second flush syringe. Drug delivery and paired flushing through the VAD delivery system also inherently expose the delivery system to potential contamination.

[0005] Bacteria and other microorganisms can enter a patient's vascular system through connections to various types of patient connectors, including access hubs, ports, and valves, when delivering fluids or medications, in non-limiting examples. Whether or not it is an access hub, port, valve, or other type of connection, each patient connector is associated with several risks of transmitting catheter-associated bloodstream infections (CRBSIs), risks that can be highly costly and potentially fatal. To reduce CRBSI cases and ensure that VADs are used and maintained appropriately, practice standards have been developed, including disinfection and cleaning procedures. Disinfectant caps have been added to the Society for Healthcare Epidemiology (SHEA) guidelines, and caps are also incorporated into the Infusion Nursing Practice (INS) guidelines.

[0006] In advanced markets, when using IV catheters, a needleless patient connector is typically used to close the system and then accessed through the catheter to administer medication or other necessary fluids to the patient. INS practice standards recommend the use of needleless connectors and state that "prior to each access, they should be thoroughly disinfected with alcohol, iodine tincture, or a chlorhexidine gluconate / alcohol combination." Disinfection of needleless connectors is ultimately intended to help reduce bacteria that inhabit the surface and potentially lead to various catheter-related complications, including CRBSI. Nurses typically complete this disinfection by using 70% isopropyl alcohol (IPA) pads and performing what is known as "hub scrubbing." Currently, many nursing units mandate the practice of scrubbing patient IV connector hubs, even if the connector is connected to an existing disinfectant cap.

[0007] Typically, in a saline-drug-saline (SAS) workflow process, administering a single drug via a VAD system requires four scrubbing procedures (often performed using a disinfectant cap). The first disinfectant scrub prepares the patient's VAD connector for drug delivery and acceptance of the first flushing syringe, and verifies the patency of the VAD delivery system and its IV catheter. The first flushing syringe is removed after pre-flushing is complete. Subsequently, a second disinfectant scrub prepares the catheter hub for connection to the drug delivery syringe. A third disinfectant scrub prepares the catheter hub for connection to the second flushing syringe to complete the post-drug delivery flush. Finally, after removal of the second flushing syringe, a fourth disinfectant scrub is performed, followed by sealing the catheter hub with a cap or locking syringe. If the IV catheter is locked with a fluid other than saline (such as heparin), or in the case of a saline-drug administration-saline-heparin (SASH) workflow process, a third heparin flushing procedure is required after the second saline flush, which requires a third flush syringe and a fifth disinfectant scrub. If the patient is administered one or more drugs, hub disinfection follows each additional drug administration during the workflow process, before initiating the next distribution task.

[0008] Therefore, the best practice for preventing contamination of IV catheters is to prohibit the reuse of syringe connectors to patient port connectors, as there is a risk of contamination and microbial transmission that can cause CRBSI each time the syringe is connected to or removed from the patient's VAD connector throughout the series of procedures necessary to prevent blockage in the VAD system and to administer medication to the patient.

[0009] Next, returning to the procedure of preparing the patient port for drug administration, after the initial IV port scrubbing, flushing with a first sterile single-use flush syringe is performed, followed by the healthcare worker scrubbing the IV port again and administering an equivalent amount of drug solution with a new sterile single-use drug syringe, followed by post-administration scrubbing and flushing with a second sterile single-use flush syringe. In clinical practice, the initial IV port flush, intravenous drug administration, and the second IV flush following drug administration typically use three separate single-use syringes. During drug administration, there is a risk that healthcare workers may reuse contaminated single-use flushing syringes to perform pre- and post-administration flushing. Reusing flush syringes previously connected to a patient's IV port increases the risk of transmitting catheter-associated bloodstream infections (CRBSIs) to the patient. [Prior art documents] [Patent Documents]

[0010] [Patent Document 1] U.S. Patent No. 8632521 [Overview of the project] [Problems that the invention aims to solve]

[0011] However, it is recognized that reducing the number of syringes needed to flush a patient's IV port and administer medication, while adhering to CRBSI reduction practices, is beneficial in many ways. Reduced syringe use lessens the time and effort physicians need to open fewer sterile syringe packages, and it also reduces the cost of checking syringe inventory, associated purchase costs, and medical waste disposal costs. [Means for solving the problem]

[0012] overview The flush syringe incorporates a syringe coupler, which facilitates the distribution of intravenous flushing fluid to the patient's vascular access device (VAD) twice (e.g., before and after drug administration) with a reduced risk of VAD infection. Embodiments of the syringe of this disclosure connect an unused, sterile Luer connector to each of the two flushing procedures. The distal axial end of the syringe coupler provides a first sterile Luer connector for connection to the corresponding Hub Luer connector of the VAD, and the proximal end of the syringe coupler establishes a sterile fluid seal with the corresponding barrel Luer connector of the syringe barrel.

[0013] When the syringe coupler is removed from the syringe's still sterile barrel Luer connector, the syringe barrel Luer connector is immediately connected directly to the re-sterilized VAD's hub Luer connector. More specifically, the syringe coupler has a female first Luer connector at its proximal end, which is detachably connected to the syringe's male barrel Luer connector, isolating the male barrel Luer connector and the flushing fluid in the syringe barrel from environmental contamination. A male second Luer connector at the distal end of the housing is fitted into the patient's connected insertion into the VAD, delivering at least a portion of the flushing fluid held in the syringe. Typically, after the initial VAD flushing procedure, the clinician sterilizes the VAD, administers one or more drugs to the patient through the VAD, and sterilizes the VAD after each administration of new drugs. After the initial flushing procedure, the syringe coupler is disconnected from both the VAD and the syringe's male barrel Luer connector. Subsequently, an unused, sterile barrel Luer connector is directly connected to the VAD for the distribution of a second portion of the flushing fluid. Each VAD connection by the syringe is made using an unused, sterile connector. The VAD connector on the syringe is not reused. Thus, a single IV flush syringe can be used to perform both pre- and post-drug flushing of the patient's IV port. This can result in a 50% reduction in the number of flush syringes required to administer medication to the patient, while still adhering to best CRBSI reduction practices. The reduction in syringe use also reduces associated syringe inventory and medical waste disposal costs. Some embodiments of the flush syringe incorporate a tamper-evident end cap that visually identifies whether the first Luer connector has been used previously. Other embodiments of the flush syringe incorporate a twist-lock mechanism that passively separates the syringe coupler from the syringe barrel after the first use of the first Luer connector and its removal from the VAD.

[0014] One aspect of the present disclosure relates to a flush syringe for intravenous fluid administration to a patient. In some embodiments, the syringe is pre-filled with flushing fluid and packaged in a sterile packaging. The syringe includes a syringe barrel having a distal end, an open proximal end, and a syringe cavity within the barrel. A syringe plunger is movable within the syringe cavity. A male barrel Luer connector has a male barrel Luer tip oriented at the distal end of the syringe barrel and defining an outlet lumen communicating with the syringe cavity. A syringe coupler includes a housing connected to the syringe and having proximal and distal axial ends, as well as a central axis, the housing comprising a female first Luer connector at the proximal end of the housing, coaxial with the central axis, the first Luer connector having a first lumen defined therein. The syringe coupler also has a male second Luer connector at the distal end of the housing, coaxial with the central axis, which has a male Luer tip with a defined second lumen. The first and second lumens are in fluid communication with each other. A storage cap is attached to the housing, covers the male second Luer connector, and seals the second lumen. The female first Luer connector of the housing is fitted into a coupled receptacle to a male barrel Luer connector, delivering the flushing fluid held in the syringe cavity to the first and second lumens of the housing through the outlet lumen of the male barrel Luer connector. The male second Luer connector of the housing is fitted into a coupled insertion to the patient's corresponding needleless IV connector or other type of VAD, delivering at least a portion of the flushing fluid held in the syringe cavity to the IV connector. The syringe coupler is selectively detachable from the male barrel Luer connector, allowing the male barrel Luer connector to be directly connected to the corresponding needleless IV connector, and delivering additional flushing fluid held in the syringe cavity to the IV connector.

[0015] Another aspect of the present disclosure relates to a method for manufacturing the aforementioned flush syringe. During the manufacture of such a syringe, the syringe barrel is provided with a male barrel Luer connector oriented at the distal end of the syringe barrel, an open proximal end, and a syringe cavity within the barrel. The barrel Luer connector of the syringe has a male barrel Luer tip defining an outlet lumen that communicates with the syringe cavity. A syringe coupler is provided, including a housing having proximal and distal axial ends and a central axis. A female first Luer connector is oriented at the proximal end of the housing, coaxial with the central axis, and has a first lumen defined therein. A male second Luer connector is oriented at the distal end of the housing, coaxial with the central axis, and has a male Luer tip with a second lumen defined therein. The first and second lumens are in fluid communication with each other. The female first Luer connector is coupled to the barrel Luer connector. In some embodiments, a selectively removable storage cap is coupled to the housing, covering the male second Luer connector of the syringe coupler and sealing the second lumen. In some embodiments, during syringe manufacturing, the syringe cavity is pre-filled with flushing fluid. A movable syringe plunger is then inserted into the syringe barrel within the syringe cavity. In some embodiments, after insertion of the syringe plunger, the assembled flush syringe is sterilized and packaged in a sterile packaging container. In some embodiments, multiple flush syringes are packaged in a common sterile packaging container.

[0016] Further aspects of this disclosure relate to a method for flushing a patient port during intravenous fluid administration to a patient using the flush syringe described above and above. When performing this flushing method, it is assumed that the administering clinician will follow approved medical protocols to reduce the possibility of VAD contamination. The clinician disinfects the hub of the patient port having a hub Luer connector or other VAD. After removing the flush syringe from its sterile packaging and subsequently removing the storage cap from the syringe coupler, the male second Luer connector of the syringe coupler is connected to the hub Luer connector of the patient port. By pressing down the syringe plunger, a first portion of the pre-filled flushing fluid, held in the syringe cavity, is distributed to the patient port via the male second Luer connector of the syringe coupler. The male second Luer connector is detached from the hub Luer connector, and the hub of the patient port is disinfected. One or more drugs are then administered through the hub using a drug delivery syringe, and the hub is disinfected after the delivery of each drug. The syringe coupler is detached from the syringe by disconnecting the female first Luer connector from the male barrel Luer connector of the syringe. The syringe coupler is then discarded. To prepare for the second VAD flushing procedure, the patient port hub is disinfected, the male barrel Luer connector is connected to the patient port hub Luer connector, and the syringe plunger is pushed down, distributing a second portion of the pre-filled flushing fluid held in the syringe cavity through the male barrel Luer connector to the patient port. The male barrel Luer connector is then disconnected from the patient port hub Luer connector, and the syringe is discarded. The patient port hub is disinfected again and covered with a sterile hub cap.

[0017] Exemplary embodiments of this disclosure are described further in the following detailed description in conjunction with the accompanying drawings. [Brief explanation of the drawing]

[0018] [Figure 1] This is an isometric view of an embodiment of the flash syringe disclosed herein. [Figure 2] It is a partial axial sectional view of the syringe of FIG. 1. [Figure 3] It is an isometric view of the syringe of FIG. 1, coupled to a VAD of an exemplary needleless connector (NFC) patient port type for the initial delivery of flushing fluid to the VAD. [Figure 4] It is an enlarged axial sectional view of the connected syringe coupler / syringe and the patient port of FIG. 3. [Figure 5] It is an isometric view of the syringe of FIG. 3, after flushing the patient port with a portion of the flushing fluid pre - contained within the syringe and disconnecting the syringe coupler from both the patient port and the syringe barrel. [Figure 6] It is an isometric view of the syringe of FIG. 3, after directly connecting its barrel luer connector to the patient port to flush the patient port a second time using the residual flushing fluid remaining within the syringe after the first flushing procedure. [Figure 7] It is a partial isometric elevation view of another embodiment of the flush syringe of the present disclosure, having an anti - tampering peel cap. [Figure 8] It is a partial sectional view of the flush syringe of FIG. 7. [Figure 9] It is an isometric view of another embodiment of the flush syringe, after removing the anti - tampering storage cap and prior to connecting it to the patient port. [Figure 10] It is a partial exploded elevation view of the flush syringe of FIG. 9. [Figure 11] It is a partial isometric view of the distal end of the flush syringe of FIG. 9. [Figure 12] It is a partial axial sectional view of the flush syringe of FIG. 9, showing an embodiment of a first end cap for sealing the second lumen of the syringe coupler. [Figure 13] It is a partial axial sectional view of the flush syringe of FIG. 9, showing an embodiment of a second end cap for sealing the second lumen of the syringe coupler. [Figure 14]Figure 9 is an isometric view of a portion of the flush syringe after the fragile tear-off ring, which is designed to prevent tampering, has been removed. [Figure 15] Figure 9 is a partial isometric view of the flush syringe after the tamper-proof tear ring has been removed and the syringe coupler has been attached to the patient port. [Figure 16] Figure 9 is a partial isometric view of the flush syringe after the syringe coupler has been removed from the syringe. [Figure 17] Figure 9 is an isometric view of the syringe after its barrel Luer connector has been directly connected to the patient port in order to flush the patient port a second time using the remaining flushing fluid in the syringe after the initial flushing procedure. [Figure 18] This is an isometric view of another embodiment of the flash syringe of the present disclosure, which has a twist-lock mechanism for passively separating the syringe coupler from the syringe barrel. [Figure 19] Figure 18 is an isoangular view of the distal end of the flash syringe. [Figure 20] Figure 18 is a partial axial cross-sectional view of the flash syringe. [Figure 21] Figure 18 is a magnified layer view of the distal end of the flush syringe before the storage cap is removed and the syringe coupler is attached to the patient's VAD. [Figure 22] Figure 18 is a magnified layered view of the distal end of the flush syringe during removal of the syringe coupler from the barrel luer connector.

[0019] To facilitate understanding, the same reference numbers are used whenever possible to indicate identical elements common to the figures. The figures are not drawn to scale. [Modes for carrying out the invention]

[0020] Detailed explanation Embodiments of the flush syringe disclosed herein facilitate two separate drainages and deliveries of intravenous flushing fluid contained in the flush syringe to the patient's vascular access device (VAD) with a reduced risk of VAD contamination. Each of the two separate syringe connections to the VAD is made using a new, sterile VAD connector. The flush syringe disclosed herein has two separate sterile rear connectors available for connection to the VAD hub connector, thus enabling two separate drainages of uncontaminated flushing fluid to the patient's VAD before and after drug administration. In this way, the clinician has the ability to first flush the patient's VAD via a male Luer connector at the distal end of the syringe coupler, which is oriented between the VAD and the flushing fluid contained in the flush syringe, and is in fluid communication with both. The syringe coupler has a female Luer connector at its proximal end, which is detachably connected to the male barrel Luer connector of the syringe, thereby isolating the male barrel Luer connector of the syringe and the flushing fluid in the syringe barrel from environmental contamination. After the initial flushing procedure, the male Luer connector of the syringe coupler is removed from the patient's VAD. Typically, after the initial VAD flushing procedure, the clinician disinfects the VAD and administers one or more drugs to the patient through the VAD, disinfecting the VAD after each new drug administration. After the completion of drug administration, the female Luer connector of the syringe coupler is removed from the uncontaminated male barrel Luer connector of the syringe. The uncontaminated barrel Luer connector is then connected directly to the VAD to distribute a second portion of the flushing fluid. Some embodiments disclosed herein incorporate a tamper-evident cap and provide a visual indicator to the clinician of whether the syringe coupler has been used previously. Other embodiments incorporate a twist-lock mechanism that passively separates the syringe coupler from the syringe barrel when the male second Luer connector is removed from the patient port, so that the syringe coupler cannot be reused. Yet another embodiment incorporates both a tamper-evident cap and a twist-lock mechanism.

[0021] In this disclosure, the distal end of the device is the end closest to the patient, for example, for delivering one or more drugs to the patient, and the proximal end of the device is the end furthest from the patient, closest to the clinician or other healthcare professional. The following definitions are provided for terms used in this disclosure.

[0022] The use of "a," "an," and "the" in this book includes both singular and plural forms.

[0023] As used herein, the term “Luer connector” refers to a connecting collar, a standard method for attaching syringes, catheters, hub needles, IV tubes, etc., to one another. A Luer connector consists of slightly tapered male and female connecting tubes that securely connect by simple pressure / twist fit alone. Luer connectors optionally include an additional outer threaded rim, which allows them to be more secure. The male end of a Luer connector can be integrated with a flush syringe and connected to the female end positioned on a vascular access device (VAD). A Luer connector also has a distal end channel for releasably attaching the Luer connector to the hub of a VAD and a proximal end channel for releasably attaching the Luer connector to the barrel of a syringe.

[0024] As used herein, ISO 80369-7:2016 defines the specifications for a standard Luer connector, which includes a 6% taper between the distal and proximal ends. A male standard Luer connector increases from the open distal end to the proximal end. A female standard Luer connector decreases from the open proximal end to the distal end. According to ISO 80369-7:2016, a male standard Luer connector has an outer cross-sectional diameter between 3.970 mm and 4.072 mm, measured at a position 0.75 mm from the distal end of the tip. The length of the male standard Luer taper is between 7,500 mm and 10,500 mm. The outer cross-sectional diameter measured at a position 7,500 mm from the distal end of the tip is between 4.376 mm and 4.476 mm. As used herein, the terms “male standard luer connector” and “female standard luer connector” refer to connectors having the dimensions described in ISO 80369-7, which is incorporated herein by reference in whole.

[0025] Throughout this specification, descriptive terms such as “tip,” “hub,” “screw,” “projection / insertion,” “tab,” “inclined,” “wall,” “top,” “side,” “bottom,” and others are used to facilitate understanding, but are not intended to limit any components that may be used in combination or individually, nor are they intended to require any particular spatial orientation to implement various embodiments of the embodiments of this disclosure.

[0026] Before describing some exemplary embodiments of this disclosure, it should be understood that this disclosure is not limited to the configuration or method step details described below. Other embodiments of this disclosure are possible and can be practiced or implemented in many ways.

[0027] The examples provided in this description are provided to aid in a comprehensive understanding of the exemplary embodiments of this disclosure. Those skilled in the art will understand that various changes and modifications of the embodiments described herein can be made without departing from the scope and spirit of this disclosure. Furthermore, for clarity and brevity, descriptions of well-known functions and configurations are omitted.

[0028] In exemplary implementations of embodiments of the present disclosure, the syringe barrel includes a distal end having a needleless connector. In one or more embodiments, the needleless connector includes at least one thread and other features in any combination that enables it to interact with the corresponding thread or a plurality of threads of the corresponding connector.

[0029] According to further exemplary implementations of embodiments of the present disclosure, the configuration of the structural elements constituting the needleless connector includes a collar protruding from the distal end of the barrel, the collar having at least one thread for connection to the corresponding thread or multiple threads of the corresponding connector.

[0030] According to yet another exemplary implementation of an embodiment of the present disclosure, the collar- or pinless connector bends or elastically deforms to allow for better interference fit with the corresponding connector.

[0031] According to further exemplary implementations of embodiments of the present disclosure, the pinless connector may comprise a female thread having a thread pattern and being sized to engage with a standard ISO 594-2 type male fitting, and / or a male thread having a thread pattern and being sized to engage with a standard ISO 594-2 type female fitting. An example of an ISO 594-2 type fitting is a Q-style fitting.

[0032] In one or more embodiments, the female connector may be selected from the group consisting of needle-type connectors, needleless connectors, catheter Luer connectors, stopcocks, and hemodialysis connectors, which are basically for insertion into a drug vial (for direct injection into a patient or for aspirating a drug dose from there). In one or more embodiments, the needleless connector is selected from Q-style connectors, MaxPlus, MaxPlus Clear, MaxZero, UltraSite, Caresite, InVision-Plus, Safeline, OneLink, V-Link, ClearLink, NeutraClear, Clave, MicroClave, MicroClave Clear, Neutron, NanoClave, Kendall, Nexus, InVision, Vadsite, Bionector, and the like.

[0033] In one or more embodiments, the male connector may be the end of an intravenous tube or a stopcock.

[0034] Next, referring to the drawings, a first aspect of the present disclosure is shown in Figures 1-6, and the flush syringe 30 shown below, removed from its sterile packaging 31, comprises a syringe barrel 32 defining a distal end 34 and an open proximal end 36, and a syringe plunger 38 held in an internal syringe cavity 40. In some embodiments, the syringe cavity 40 is pre-filled with flushing fluid 42 during the manufacture of the syringe. In some embodiments, the volume of the flushing fluid 42 held in the syringe cavity 40 is 10 ml. The conical distal end 34 of the syringe barrel 32 incorporates a threaded male barrel Luer connector 44, which connects to a syringe coupler 46. The barrel Luer connector 44 includes a male barrel Luer tip 50 having a tapered outer surface 51 terminating at the distal end face 52. An outlet lumen 54 formed on the distal end face 52 of the barrel luer tip 50 is in fluid communication with the syringe cavity 28. The threaded male barrel luer connector 44 has a collar 48 with at least one inward thread 56 surrounding the barrel luer tip 50. The syringe plunger 38 advances in the direction of arrow D and distributes the flushing fluid 42 under pressure from the syringe cavity 40 through the outlet lumen 54 of the barrel luer connector 44.

[0035] As described above, in some embodiments, such as the flush syringe 30 in Figure 1, the syringe cavity 40 is pre-filled with flushing fluid 42, the proximal axial end of the syringe coupler 46 is connected to a barrel Luer connector 44, and a flip cap 80 (also referred to herein as an end cap) is coupled to the distal end of the syringe coupler to hold the flushing fluid within the syringe. Typically, the assembled and pre-filled flush syringe 30, syringe coupler 46, and flip cap 80 are pre-packaged in a sterile packaging 31. In some embodiments, multiple flush syringes 30 are packaged separately in a common sterile packaging container. An exemplary flush syringe is shown and described in Patent Document 1, titled “Syringe Assembly,” the entire contents of which are incorporated herein by reference in all jurisdictions where the patent law permits such incorporation.

[0036] Referring more closely to the cross-sectional views in Figures 2 and 4, the syringe coupler 46 comprises a housing 58 having a proximal axial end 60 and a distal axial end 62. The housing 58 defines a central axis. At the proximal axial end 60 of the housing 58, a threaded female first Luer connector 64 defines a female Luer tapered surface 65 and an external thread 66, which are oriented coaxially with the central axis and terminate at the proximal end face 67. The external thread 66 of the female first Luer connector 64 is in mating engagement with a corresponding inward thread 56 formed in the collar 48 of the male barrel Luer connector 44. The first lumen 68 of the female first Luer connector 64 has an inlet 70 formed in the seating surface 71 of the housing 58. The first lumen 68 is in fluid communication with the outlet lumen 54 of the barrel Luer connector 44. A threaded male second Luer connector 72 at the distal end 62 of the housing 58 is oriented coaxially with the central axis and includes a tapered male Luer tip 74. A second lumen 75 is formed within the male Luer tip 74 and is in fluid communication with the first lumen 68 of the female first Luer connector 64, which are interconnected. The male second Luer connector 72 incorporates a collar 76 defining at least one inward thread 78.

[0037] Next, referring to Figures 1-3, the storage or end cap of the syringe coupler 46 is a flip cap 80 having an outer distal end face 82, an inner surface 84, and a peripheral wall 86. When the flip cap 80 covers the distal end 62 of the housing 58 of the syringe coupler 46, a male sprue 88 formed on the inner surface 84 is inserted into the second lumen 75 of the male second Luer connector 72, preventing leakage of the flushing fluid 42 from the syringe. The closed flip cap 80 also maintains the sterility of the male second Luer connector 72. A lift tab 90 facilitates the separation of the flip cap 80 from the syringe coupler 46, exposing the male second Luer connector as shown in Figure 3. In some embodiments, tamper-evident tape or shrink seal is applied to the flip cap 80 and housing 58 to provide a visual indicator to the clinician of whether the syringe 30 has been used previously. The cap hinge 92 connects the flip cap 80 and the housing 58 to connect the flip cap to the coupler housing. The cap hinge 92 is formed integrally with the housing 58 and the flip cap 80, but in other embodiments, one or more of these components are manufactured separately and then connected together.

[0038] Figures 3 and 4 show the connection of the male second Luer connector 72 of the syringe coupler 46 to a patient port, such as a needleless connection (NFC) type patient port 94. The patient port 94 has a patient IV catheter 96, a hub 98, and a threaded female hub Luer connector 100 with an external thread 102. At least one inward thread 78 formed on the collar 76 of the male second Luer connector 72 engages with the external thread 102 of the female hub Luer connector 100. During SASH administration, after the initial flushing of the patient port 94 with the flush syringe 30, the syringe coupler 46 is detached from the patient port and then detached from the barrel Luer connector 44 of the syringe (Figure 5). After drug administration and disinfection of the patient port 94, the barrel Luer connector 44 is attached directly to the patient port for follow-up flushing (Figure 6). The male second Luer connector 72 and male barrel Luer connector 44 in Figures 2 and 4 have an interchangeable structure, and either of these male connectors can be intentionally connected to the corresponding hub Luer connector of a patient port, such as the needleless connection (NFC) type patient port 94 in Figures 3, 4, and 6, for the purpose of flushing the port.

[0039] The flush fluid path established within the syringe coupler 46 allows for the delivery of flushing fluid to patient ports, such as the patient port 94, when the port is coupled to the second male Luer connector 72, just as it would be when directly connected to the barrel Luer connector 44. In the embodiments shown in Figures 1-6, the first lumen 68 and the second lumen 75 of the housing 58 of the syringe coupler are coupled to each other, forming a common fluid path with an inlet 70 and a flow direction starting from the seating surface 71 of the female first Luer connector 64 of the housing 58 and flowing out from the distal end of the male Luer tip 74 of the male second Luer connector 72. Typically, in the first flush via the male second Luer connector 72, 5 ml of flushing fluid is distributed from the syringe cavity 40 to the hub Luer connector 100, which is half of the 10 ml capacity of the syringe cavity. After connecting the barrel lure connector 44 to the hub lure connector 100, the flushing fluid remaining in the syringe cavity 40 is distributed to the hub lure connector.

[0040] Figures 7 and 8 show another embodiment of a flush syringe 103 equipped with a syringe coupler 104, the syringe coupler 104 incorporating a release lid 126 type storage or end cap to cover and seal its distal end. The release lid 126 advantageously provides a visual indicator of tamper-evidentness to the clinician, indicating whether the sterility of the syringe coupler 140 is compromised. The syringe coupler 104 has a housing 106 equipped with a first female Luer connector 108 and a second male Luer connector 110 having a male Luer tip 111. The seating surface 112 of the housing 106 defines a first lumen 114 of the first female Luer connector 108. The male Luer tip of the second male Luer connector 110 defines a second lumen 115. The first lumens 114 and second lumens 115 of the syringe coupler housing 106 are coupled to each other and form a common fluid path with a flow direction, starting at the seating surface 112 of the female first Luer connector 108 and flowing out from the distal end of the male Luer tip 111 of the male second Luer connector 110. The hollow sleeve 116 is held within the common fluid path of the housing 106, which is formed by the coupled first lumens 114 and second lumens 115. In some embodiments, the hollow sleeve 116 is coupled to the housing 106 within the common fluid path. The proximal axial end of the hollow sleeve 116 protrudes from the seating surface 112 and the first lumen 114 toward the proximal axial end of the housing 106. The proximal axial end of the hollow sleeve 116 is inserted into the outlet lumen 54 of the male barrel Luer tip 50. In some embodiments, the insertion of the hollow sleeve 116 into the outlet lumen 54 effectively isolates the outlet of the barrel Luer connector 44 and the syringe cavity 40 from external contamination. The insertion of the proximal axial end of the hollow sleeve 116 into the outlet lumen 54 creates a flow path or route for the distribution of the flushing fluid 42 held in the syringe cavity 40 through the hollow sleeve lumen 118 of the hollow sleeve to the second lumen 115 of the male second Luer connector 110 of the housing. In other embodiments of the syringe coupler 104, the structure of the respective Luer connectors 108 and 110 and their internal fluid passage connections are identical to those of the syringe coupler 46.

[0041] The distal end of the housing 106 of the flash syringe 103 incorporates a circumferential cup 120 projecting radially from the central axis of the housing and axially from the distal end of the housing. The circumferential cup 120 defines a distal axial surface 122, which is covered by a peel-back cover 126 together with the distal tip surface 124 of the male second Luer connector 110. In one or more embodiments, the peel-back cover 126 is a peelable seal, which comprises a peel-back top of aluminum or a multilayer polymer film. The peel-back cover 126 comprises a distal outer surface 128 and a proximal inner surface 130 which is bonded or adhered to the distal axial surface 122 of the circumferential cup 120 and the distal tip surface 124 of the male second Luer connector. The sealing configuration of the release lid 126 provides sufficient environmental sealing between the aluminum or polymer film on its proximal inner surface 130 and the distal axial surface 122 of the circumferential cup 120, which is bonded to the opposite side, as well as between the distal tip surface 124 of the male second Luer connector 110, which is bonded to the opposite side, within the range of temperature, pressure, and humidity levels expected in a medical facility. In some embodiments, the release lid 126 is heat-sealed or induction-sealed to the circumferential cup 120 together with the distal tip surface 124 of the male second Luer connector 110, which is bonded to the opposite side. In other embodiments, the release lid 126 is sealed to the circumferential cup 120 together with the distal tip surface 124 of the male second Luer connector 110, which is bonded to the opposite side, by a pressure-sensitive or heat-sensitive adhesive. The bonded release lid 126 maintains the sterility of the male second Luer connector 110 and prevents leakage of flushing fluid from the second lumen 115 of the connector. The release tab 132 facilitates the removal of the release cover 126 from the housing 106, exposing the male second Luer connector 110. In summary, the release cover 126 minimizes the ingress of potential particulate matter and also provides a substantially impermeable enclosure at the distal end of the housing 106, providing leak prevention and / or maintaining a sealed, sterile environment within the housing.

[0042] Figures 9–17 show another embodiment of the flush syringe 138, comprising a syringe coupler 140 incorporating a tamper-evident storage or end cap assembly 150 for covering and sealing its distal end. The end cap assembly 150 advantageously provides the clinician with a visual indicator of tamper-evident properties, indicating whether the sterility of the syringe coupler 140 has been compromised. The syringe barrel 32, syringe plunger 37, and barrel Luer connector 44 of the flush syringe 138 are identical to those of the flush syringe embodiments 30 and 103 described above in Figures 1–8. The syringe coupler 140 comprises a housing 142 with a female first Luer connector 144 at its proximal end, the female first Luer connector 144 being connected to the barrel Luer connector 44. The housing 142 further includes a male second Luer connector 146, which has a second lumen 148 for draining flushing fluid from the housing when connected to the patient port 94. In some embodiments, the syringe coupler 140 is made of a transparent or colored polymer to allow visual inspection of its internal structure. In various embodiments, the internal structure and fluid passages through the syringe coupler 140 from the internal syringe cavity 40 to the patient port 94 are identical to those in embodiments 46 and 104 of the syringe coupler in Figures 1-8.

[0043] In some embodiments, multiple syringe couplers 140 are linked and stacked in series to facilitate two or more flushing procedures from the same syringe barrel 32. When in use, the most distal syringe coupler 140 is connected to the patient port for the first flushing procedure and discarded upon completion of that procedure. The next available most distal syringe coupler 140 in the stack is used to perform a second flushing procedure, and so on.

[0044] One embodiment of the tamper-proof end cap assembly 150 comprises a male second Luer connector 146 and an end cap embodiment 152 covering its second lumen 148, a snap-on band 154, and a tear-ring type tear ring 156. The snap-on band 154 snaps onto the outer circumferential surface of the syringe coupler 140 and engages securely with the outer circumferential surface of the syringe coupler 140. The tear ring has a finger tab 158 at one end of the tear-ring structure. In this embodiment, the end cap assembly 150 is an integrated polymer structure formed by injection molding, with a plurality of integrally formed first cut-off connectors 160 connecting the end cap 152 and the tear ring 156, and a plurality of integrally formed second cut-off connectors 161 connecting the tear ring to the snap-on band 154. As shown by the surface arrows in Figure 11, separating the finger tab end of the tear ring from its opposing tear end causes both of the multiple cut connectors 160 and 161 to break, making the end cap 152 removable.

[0045] As shown in Figure 12, in the end cap assembly embodiment 150, the inner surface 162 of the axial wall of the end cap embodiment 152 defines the male sprue 164. When the end cap embodiment 152 covers the male second luer connector 146, the male sprue 164 seals the second lumen 148 within the male luer tip 166, preventing fluid leakage and maintaining the sterility of the covered luer connector. An alternative embodiment of the end cap assembly 168 shown in Figure 13 also seals the male luer tip 166. In this alternative embodiment, the end cap 170 has an inner axial wall surface 172 that defines a circumferential collar 174, which seals with the corresponding outer surface of the male luer tip 166.

[0046] In other embodiments, the tamper-evident end cap structure comprises a shrink-wrap plastic film covering the end cap, or a series of perforations, or a thinner wall structure, or another type of fragile joint, connecting the end cap to the snap-on band. In some embodiments, the snap-on band is integrally formed within the housing 142. In some embodiments, the snap-on band 154 has a contrasting visual color (e.g., red) to alert the clinician that either the end cap 152 or 170 embodiment has been removed from the syringe coupler 140 and its corresponding male second Luer connector 146 may not be sterile.

[0047] The use of the embodiment of the flush syringe 138 is as follows, referring in order to Figures 11, 14-17. For brevity, the SASH hub cleaning procedure accompanying the use of the flush syringe 138 is not described. The clinician prepares the flush syringe 138 by peeling the finger tab 158 of the tearing ring 156 from the syringe coupler 140, which tears the respective cut connectors 160 and 161 (Figure 11). The tearing ring 156 is pulled away from the snap-on band 154 and end cap 152 (Figure 14). The syringe coupler 140 is coupled to the patient port 94 to allow the initial flushing of the port (Figure 15). Upon completion of the initial flushing procedure, the syringe coupler 140 is detached from the patient port and barrel luer connector 44, and it is then discarded (Figure 16). After administering the drug to the patient, the barrel Luer connector 44 is directly connected to the patient port 94, which allows for the administration of a second flushing procedure (Figure 17), as described with respect to the embodiment of the flush syringe 30 in Figures 1-6.

[0048] Figures 18-22 show another embodiment of the flush syringe 178 with a twist-lock mechanism, which prevents inadvertent axial separation of the barrel Luer connector 44 from the syringe coupler 180 when the twist-lock mechanism is engaged in a first position prior to the screw-in engagement of the syringe coupler to the patient port 94. Conversely, when the syringe coupler 180 is screwed back / removed from the patient port 94, the twist-lock mechanism is passively disengaged in a second position, which facilitates the passive separation of the syringe coupler 180 from the barrel Luer connector 44. After the syringe coupler 180 is removed from the patient port or other VAD, the passive separation of the syringe coupler 180 from the barrel Luer connector 44 prevents the syringe coupler 180 from being inadvertently reused after its first use of the first Luer connector of the syringe coupler 180.

[0049] As shown in Figure 18, the flush syringe 178 is secured to the patient port 94 by a relative clockwise rotation (plane arrow T), engaging the twist-lock mechanism in its first position. When the flush syringe 178 is removed from the patient port 94 by a relative counterclockwise rotation (plane arrow R), the flush syringe 178 moves the twist-lock mechanism to its second position.

[0050] The syringe barrel 32, syringe plunger 37, and barrel Luer connector 44 of the flash syringe 178 are identical to those of the flash syringe embodiments 30 and 103 described above in Figures 1-8. The syringe coupler 180 comprises a housing 182, which has a female first Luer connector 184 at the proximal end of the housing that is coupled to the barrel Luer connector 44. The housing 182 further comprises a male second Luer connector 186 for connection to a patient port 94, a flip-cap type end or storage cap 188, and a flip-cap hinge 190. The structure, function, and operation of the flip-cap 188 and flip-cap hinge 190 are the same as those of the flip-cap 80 and flip-cap hinge 92 of the flash syringe 30 in Figures 1-6. In various embodiments, the internal structure and the fluid passage through the syringe coupler 180 from the internal syringe cavity 40 to the patient port 94 are identical to those of the syringe coupler embodiments 46 and 104 in Figures 1-8.

[0051] Referring more specifically to Figures 19-22, the twistlock mechanism comprises a hollow connecting sleeve 192, which has a proximal end with an inner surface that fits into the outer circumferential surface of the collar 48 of the male barrel Luer connector 44. In this embodiment, the connecting sleeve 192 is a separate component securely coupled to the barrel Luer connector 44. In this way, the connecting sleeve 192 allows for the integration of the twistlock mechanism into an existing flush syringe. In other embodiments, the connecting sleeve 192 is integrally formed within the barrel Luer connector 44. The twistlock mechanism further comprises a cup-shaped housing skirt 194 formed within the housing 182, midway between the first female Luer connector 184 and the second male Luer connector 186. The housing skirt 194 surrounds the central axis and the first female Luer connector 184 and extends axially toward the proximal end of the housing. The housing skirt 194 has an axial extension 196, which holds skirt pins 198 that extend radially inward toward the central axis of the housing 182. The distal end 193 and outer surface of the connecting sleeve 192 are received within the housing skirt 194 and are rotatable.

[0052] When the syringe barrel 32 is rotated relative to the housing 182 of the syringe coupler 180, such as during connection or disconnection of the barrel luer connector 44 to the female first luer connector 184, the connecting sleeve 192, which is securely coupled to the barrel luer connector, also rotates relative to the housing skirt. If the opposing threads of the barrel luer connector 44 and the female first luer connector 184 do not engage, the collar is axially separable from the housing 182 and the housing skirt 194. Referring to Figures 21 and 22, the axial separation and relative rotation between the connecting sleeve 192 and the housing skirt 194 are received by a substantially S-shaped cam slot 200 formed on the outer circumferential surface of the connecting sleeve 192 and are restrained by the movement of a skirt pin 198 traveling within the slot. Other embodiments of the flush syringe incorporate multiple pairs of skirt pins 198 and cam slots 200.

[0053] In Figure 21, when the first female Luer connector 184 and the barrel Luer connector 44 are fully tightened in a fluid-seal engagement state (plane arrow T), the skirt pin 198 is oriented in the cam slot 200 to the aforementioned first position 202. The orientation of the skirt pin 198 in the first position 202 (and the tightened first female Luer connector 184 and barrel Luer connector 44) prevents relative axial separation of the housing 182 and the coupling sleeve 192 / syringe. As shown in Figures 18 and 22, when the syringe coupler 180 is unscrewed from the patient port 94 (plane arrow R), the coupling sleeve 192 also rotates in the same direction (plane arrow I), biasing the claw 206 toward the housing skirt 194, after which the skirt pin 198 travels along the cam slot 200 to its second position 204. The claw 206 prevents the skirt pin 198 from moving unintentionally from the first position 202 to the second position 204. When the syringe coupler 180 is fully unscrewed from both the patient port 94 and the syringe barrel 32, the axial retraction (plane arrow II) of the flush syringe 30 passively separates the syringe coupler 180 from the patient port 94, but not from the syringe barrel. This is because the retention of the skirt pin 198 in the second position 204 prevents complete axial separation of the syringe coupler 180 and the flush syringe 30. If it is desired to separate the syringe coupler 180 from the syringe barrel 32, the skirt pin 198 is moved out of the cam slot 200 along the path indicated by the plane arrow III. The separated flush syringe 30 is then available for direct connection to the patient port 94 for administration of a second port flushing procedure, as described with respect to the embodiment of the flush syringe 30 in Figures 1-6.

[0054] The components of embodiments 30, 103, 138, and 178 of the flash syringe, as well as those of other embodiments described herein, are manufactured by injection molding or vacuum thermoforming. The exemplary materials used to manufacture the syringe coupler and its end / storage cap include thermoplastic polymers. The hollow sleeve 116 is an elastomer sleeve manufactured by compression molding of a cross-linked rubber or thermoplastic elastomer material. Generally, the components of embodiments 30, 103, 138, and 178 of the flash syringe are manufactured from a variety of medical-grade plastic materials, such as polycarbonate, polypropylene, polyethylene, glycol-modified polyethylene terephthalate, acrylonitrile butadiene styrene, or any other moldable plastic material used in medical devices.

[0055] One or more embodiments of the flash syringes described herein are manufactured as follows. In one exemplary manufacturing embodiment, referring to the flash syringe 30 of Figures 1-6, a flash syringe 30 is provided, which generally comprises a syringe barrel 32 having a male barrel Luer connector 44 oriented at the distal end 34 of the syringe barrel, an open proximal end 36, and a syringe cavity 40 within the barrel. In some embodiments, the barrel Luer connector 44 has a male barrel Luer tip 50 defining an outlet lumen 54 communicating with the syringe cavity 40. In some embodiments, an existing off-the-shelf 10 ml capacity flash syringe is used to manufacture the continuous delivery flash syringe 30 of this disclosure.

[0056] Embodiments of the manufactured flash syringe 30 incorporate a syringe coupler 46, which includes the aforementioned housing 58 having a proximal axial end 60 and a distal axial end 62 and a central axis, and a female first Luer connector 64 at the proximal end of the housing, oriented coaxially with the central axis and having a defined first lumen 68 therein. The syringe coupler 46 further comprises a male second Luer connector 72 at the distal end of the housing, oriented coaxially with the central axis, the male Luer tip 74 having a second lumen 75. The first lumen 68 and the second lumen 75 are in fluid communication with each other. The female first Luer connector 64 is connected to a barrel Luer connector 44. A storage cap or end cap (here, a flip cap 80) is connected to the male second Luer connector 72 of the syringe coupler 46. Before insertion of the syringe plunger 38 into the syringe barrel 32 within the syringe cavity, the syringe cavity 40 is pre-filled with flushing fluid 42. In some embodiments, the completed pre-filled flush syringe is sterilized and packaged in a sterile packaging 31. In some embodiments, multiple flush syringes 30 are packaged in a common sterile packaging container.

[0057] In another exemplary manufacturing method, referring to the flush syringe 138 in Figures 9-17, the monolithically molded tamper-evident end cap assembly 150 is connected to the syringe coupler 140 by advancing the snap-on band 154 on the housing 142. The other steps for manufacturing the flush syringe 138 are the same as those for manufacturing the flush syringe 30.

[0058] In another exemplary manufacturing method, referring to the flush syringe 178 in Figures 18-22, the coupling sleeve 192 is firmly coupled to the male barrel Luer connector 44 before the syringe coupler 180 is coupled to the barrel Luer connector 44. As the barrel Luer connector 44 is advanced into axial alignment with the female first Luer connector 184 and screwed in there, the axial extension 196 of the housing skirt 194 is displaced outward from the syringe coupler 180, removing the skirt pin 198 from contact with the coupling sleeve 192. Once the skirt pin 198 is radially aligned with the cam slot 200, the axial extension 196 is allowed to relax to its non-displaced state, thereby orienting the skirt pin into the cam slot 200. The syringe barrel 32 is rotated counterclockwise, orienting the skirt pin 198 to a first position 202 within the cam slot 200. The other steps for manufacturing the flash syringe 138 are the same as those for manufacturing the flash syringe 30. Embodiment Embodiment (a): A flush syringe for intravenous fluid administration to a patient, the flush syringe comprising: a syringe barrel having a distal end, an open proximal end, and a syringe cavity within the syringe barrel; a syringe plunger movable within the syringe cavity; a male barrel Luer connector having a male barrel Luer tip oriented at the distal end of the syringe barrel and defining an outlet lumen communicating with the syringe cavity; and a syringe coupler, the syringe coupler The housing comprises a housing having a proximal shaft end, a distal shaft end and a central shaft, a female first Luer connector at the proximal shaft end of the housing, the female first Luer connector being coaxial with the central shaft and having a defined first lumen therein, and a male second Luer connector at the distal shaft end of the housing, the male second Luer connector being coaxial with the central shaft, its male Luer tip having a defined second lumen therein that is in fluid communication with the first lumen. A flush syringe comprising: an A connector; a storage cap connected to a housing, covering a male second Luer connector and sealing a second lumen, wherein a female first Luer connector of the housing is connected to a male barrel Luer connector to deliver flushing fluid held in the syringe cavity to the first and second lumens of the housing through the outlet lumen of the male barrel Luer connector; the male second Luer connector of the housing is adapted to connected insertion into a corresponding needleless IV connector of a patient to deliver at least a portion of the flushing fluid held in the syringe cavity to the IV connector through the second lumen; and a syringe coupler which is selectively detachable from the male barrel Luer connector, thereby allowing the male barrel Luer connector to be directly connected to a corresponding needleless IV connector to deliver additional flushing fluid held in the syringe cavity to the IV connector.

[0059] Embodiment (b): A flash syringe according to Embodiment (a), further comprising a hollow sleeve held within a first lumen, the proximal axial end of the hollow sleeve protruding from the first lumen toward the proximal axial end of the housing and inserted into the exit of a male barrel Luer tip.

[0060] Embodiment (c): A flush syringe according to Embodiment (a), wherein the storage cap further comprises a selectively removable flip cap connected to the distal end of the syringe coupler.

[0061] Embodiment (d): A flush syringe according to Embodiment (c), further comprising a flip cap and a cap hinge connected to a coupler housing, wherein the cap hinge connects the flip cap to the coupler housing.

[0062] Embodiment (e): A flush syringe according to Embodiment (a), further comprising: a circumferential cup protruding axially from the distal end of the housing and defining a distal axial plane; and a peel-off lid type storage cap connected to the distal axial plane and a second lumen of the circumferential cup.

[0063] Embodiment (f): A flush syringe according to Embodiment (a), wherein the storage cap further comprises a selectively removable end cap assembly for preventing tampering.

[0064] Embodiment (g): A flush syringe according to Embodiment (f), wherein the tamper-proof end cap assembly further comprises an end cap and a fragile tear ring connected to the end cap by at least one first cut-off connector and connected to the syringe coupler by at least one second cut-off connector.

[0065] Embodiment (h): A flush syringe of Embodiment (g), wherein the end cap assembly further comprises a monolithic end cap assembly having a snap-on band surrounding a syringe coupler; a split tear ring incorporating a finger tab; a plurality of integrally formed first cut connectors connecting the end cap and the split tear ring; and a plurality of integrally formed second cut connectors connecting the split tear ring and the snap-on band.

[0066] Embodiment (i): A flush syringe according to Embodiment (a), further comprising a twist-lock mechanism connecting the proximal end of the housing to a barrel Luer connector, wherein the twist-lock mechanism, when engaged in a first position, prevents their axial separation, and when the female first Luer connector of the housing is removed from the male barrel Luer connector, disengages in a second position, which allows such axial separation, the flush syringe.

[0067] Embodiment (j): A flash syringe according to Embodiment (i), wherein the twistlock mechanism further comprises a housing defining a housing skirt between the respective first female and second male Luer connectors, the housing skirt comprising a housing extending axially toward the proximal end of the housing and surrounding the housing and the first female Luer connector around a central axis, a skirt pin extending radially inward toward the central axis, and a hollow connecting sleeve, the hollow connecting sleeve having a proximal end with an inner surface therein that firmly receives the outer surface of a male barrel Luer connector, and the housing skirt A flush syringe comprising: a hollow connecting sleeve having a distal end with an outer surface that is received within the casing and rotatable within the housing skirt; and a cam slot formed on the outer surface of the distal end of the connecting sleeve, the cam slot receiving and capturing a skirt pin therein, the skirt pin being oriented in a first position within the cam slot when the first female Luer connector and the barrel Luer connector are fully tightened and in a fluid-seal engagement, and the skirt pin being oriented in a second position within the cam slot when the first female Luer connector and the barrel Luer connector are disconnected from each other.

[0068] Embodiment (k): A flash syringe of Embodiment (j), further comprising a male barrel Luer connector and a male second Luer connector, each having a threaded barrel, a first female, and a second male Luer connector, and a threaded collar, the threaded collars surrounding the respective male Luer tips of the male barrel Luer connector and the male second Luer connector, and a hollow connecting sleeve, the hollow connecting sleeve having a secure connection to the outer surface of the threaded collar of the corresponding male barrel Luer connector, or the male barrel Luer A flush syringe comprising: a hollow connecting sleeve formed integrally with the connector; a skirt pin, the skirt pin oriented in a first position within the cam slot when the first female Luer connector and the barrel Luer connector are fully screwed together, and the skirt pin oriented in a second position when the first female Luer connector and the barrel Luer connector are fully screwed back together; and a claw oriented in the cam slot between the first and second positions, the claw preventing the pin from unintentionally moving to the second position.

[0069] Embodiment (l): A method for manufacturing a flush syringe, the method comprising: preparing a syringe barrel, the syringe barrel comprising a male barrel Luer connector oriented at the distal end of the syringe barrel, an open proximal end, and a syringe cavity within the barrel, the barrel Luer connector having a male barrel Luer tip defining an outlet lumen communicating with the syringe cavity; and preparing a syringe coupler, the syringe coupler comprising a housing having proximal and distal axial ends and a central axis, a female first Luer connector at the proximal end of the housing, the female first Luer connector being coaxial with the central axis and having a first lumen defined therein, and a male second Luer connector at the distal end of the housing A method for manufacturing a flush syringe, comprising: providing a syringe coupler comprising a male second Luer connector having a male Luer tip coaxial with a central axis and having a second lumen that fluidly communicates with a defined first lumen therein; connecting a female first Luer connector to a barrel Luer connector; connecting a selectively removable storage cap to a housing, the storage cap covering the male second Luer connector of the syringe coupler and sealing the second lumen; pre-filling a syringe cavity with flushing fluid; and inserting a movable syringe plunger into the syringe cavity into a syringe barrel.

[0070] Embodiment (m): A method for manufacturing a flash syringe according to Embodiment (l), further comprising: sterilizing the pre-filled flash syringe after insertion of the syringe plunger; and packaging the sterilized pre-filled flash syringe in a sterile packaging container.

[0071] Embodiment (n): A method for flushing a patient port during intravenous fluid administration to a patient using the flush syringe of Embodiment (a), the method comprising: disinfecting the hub of the patient port having a hub Luer connector; removing the storage cap from the syringe coupler; connecting the male second Luer connector of the syringe coupler to the hub Luer connector of the patient port; distributing a first portion of the pre-filled flushing fluid held in the syringe cavity to the patient port through the male second Luer connector by pushing down the syringe plunger; disconnecting the male second Luer connector from the hub Luer connector; disinfecting the hub of the patient port; and administering one or more drugs through the hub using a drug administration syringe. A method for flushing a patient port, comprising: disinfecting the hub after administering each drug; detaching the female first Luer connector of the syringe coupler from the male barrel Luer connector of the syringe and then discarding the syringe coupler; disinfecting the hub of the patient port; connecting the male barrel Luer connector to the hub Luer connector of the patient port and pushing down the syringe plunger to distribute the second portion of the pre-filled flushing fluid held in the syringe cavity to the patient port through the male barrel Luer connector; detaching the male barrel Luer connector from the hub Luer connector of the patient port and then discarding the syringe; disinfecting the hub of the patient port; and covering the hub of the patient port with a sterile hub cap.

[0072] Embodiment (o): A method for flushing a patient port according to Embodiment (n), further comprising removing a flush syringe from its sterile packaging and removing a storage cap from the male second Luer connector of the syringe coupler before connecting the syringe coupler to the Hub Luer connector.

[0073] Embodiment (p): A syringe coupler for intravenous fluid administration to a patient, comprising: a syringe coupler comprising: a housing having proximal and distal axial ends and a central axis; a female first Luer connector at the proximal end of the housing, the female first Luer connector being coaxial with the central axis and having a defined first lumen therein; and a male second Luer connector at the distal end of the housing, the male second Luer connector being coaxial with the central axis and having a defined second lumen therein, which is in fluid communication with the first lumen; and a device connected to the housing, covering the male second Luer connector and sealing the second lumen. A syringe coupler comprising: a storage cap; a female first Luer connector of the housing, the female first Luer connector being fitted to the coupled receptacle of the male Luer tip of the Luer connector of the flush syringe, thereby enabling the outlet lumen formed within the male Luer tip of the syringe to fluidly communicate with the first and second lumens of the housing, and delivering flushing fluid from the flush syringe through the second lumen; and a male second Luer connector of the housing, the male second Luer connector being fitted to coupled insertion into a corresponding needleless IV connector of a patient, and delivering flushing fluid from there to the IV connector after removal of the storage cap.

[0074] Embodiment (q): A syringe coupler according to Embodiment (p), wherein the storage cap further comprises a selectively removable flip cap connected to the distal end of the syringe coupler.

[0075] Embodiment (r): A syringe coupler according to Embodiment (p), further comprising: a circumferential cup projecting axially from the distal end of the housing and defining a distal axial plane; and a peel-off lid type storage cap connected to the distal axial plane and a second lumen of the circumferential cup.

[0076] Embodiment(s): A syringe coupler of Embodiment(p), wherein the storage cap further comprises a tamper-proof, selectively removable end cap assembly.

[0077] Embodiment (t): A syringe coupler of Embodiment (s), wherein the end cap assembly further comprises an end cap and a fragile tear ring connected to the end cap by at least one first tear connector and connected to the syringe coupler by at least one second tear connector.

[0078] Embodiment (u): A syringe coupler of Embodiment (t), wherein the end cap assembly further comprises a monolithic snap-on band surrounding the syringe coupler, a split slit ring incorporating finger tabs, a plurality of integrally formed first cut connectors connecting the end cap to the split slit ring, and a plurality of integrally formed second cut connectors connecting the split slit ring to the snap-on band.

[0079] Embodiment (v): A syringe coupler of Embodiment (p), further comprising a twistlock mechanism adapted to connect the proximal end of the housing to a barrel Luer connector of a flush syringe, wherein the twistlock mechanism, when engaged in a first position, prevents their axial separation, and when the female first Luer connector of the housing is removed from the male barrel Luer connector, disengages in a second position, which allows such axial separation.

[0080] Embodiment (w): A syringe coupler of Embodiment (v), wherein the twistlock mechanism further comprises a housing defining a housing skirt between the respective first female and second male Luer connectors, the housing skirt comprising a housing, extending axially toward the proximal end of the housing, surrounding the housing and the first female Luer connector around a central axis, a skirt pin extending radially inward toward the central axis, and a hollow connecting sleeve, the hollow connecting sleeve having an inner surface fitted to securely receive the outer surface of a male barrel Luer connector therein, and an outer surface having A syringe coupler comprising: a hollow connecting sleeve having a distal end that is received within a sizing skirt and rotatable within a housing skirt; and a cam slot formed on the outer surface of the distal end of the connecting sleeve, the cam slot receiving and capturing a skirt pin therein, the skirt pin being oriented in a first position within the cam slot when the first female Luer connector and the barrel Luer connector are fully tightened into a fluid-seal engagement state, and the skirt pin being oriented in a second position within the cam slot when the first female Luer connector and the barrel Luer connector are disconnected from each other.

[0081] Embodiment (x): A syringe coupler according to Embodiment (w), further comprising a claw oriented in a cam slot between the first and second positions to prevent the pin from moving unintentionally to the second position.

[0082] Throughout this specification, any reference to “one embodiment,” “a particular embodiment,” “various embodiments,” “one or more embodiments,” or “embodiment” means that a particular feature, structure, material, or property described in relation to an embodiment is included in at least one embodiment of this disclosure. Therefore, the appearance of phrases such as “in one or more embodiments,” “a particular embodiment,” “various embodiments,” “in one embodiment,” or “in an embodiment” in various places throughout this specification does not necessarily refer to the same embodiment of this disclosure. Furthermore, a particular feature, structure, material, or property may be combined in any suitable manner in one or more embodiments. Furthermore, it should be understood that the expressions and terms used herein are for illustrative purposes only and should not be considered limiting. In this specification, “includes,” “equips,” “has,” and variations thereof mean to include the items listed thereafter and their equivalents, as well as additional items. Unless otherwise specified or limited, the terms “attached,” “connected,” “supported,” and “linked,” and variations thereof, should be interpreted broadly, encompassing direct and indirect attachment, connection, support, and linkage. Furthermore, “connected” and “linked” are not limited to physical, mechanical, or electrical connections or links.

[0083] While the disclosure herein provides explanations with reference to embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the disclosure. It will be apparent to those skilled in the art that various modifications and changes can be made to the disclosure without departing from the spirit and scope of the disclosure. For example, the structural features and operation of certain syringe coupler embodiments 46, 104, 140, and 180 are described herein. The various male and female threaded Luer connectors described are integrated not only with the syringe barrel 32 but also with the syringe couplers 46, 104, 140, and 180. In some embodiments, these Luer connectors are not threaded Luer connectors. Similarly, while the tamper-proof end cap assembly 150 is described as comprising a tear ring 156, other embodiments use other types of tamper-proof fittings. Other flush embodiments incorporate both a tamper-proof end cap structure and passive separation of the syringe coupler from the syringe barrel structure disclosed herein. This disclosure is intended to include modifications and changes that fall within the scope of the attached claims and their equivalents. The attached claims are not limited to exemplary embodiments that detail the structure and arrangement of components as described in the description or shown in the drawings.

Claims

1. A flush syringe for intravenous fluid administration to a patient, wherein the flush syringe is The syringe barrel comprises a distal end, an open proximal end, and a syringe cavity within the syringe barrel, A syringe plunger that is movable within the syringe cavity, A male barrel luer connector having a male barrel luer tip oriented at the distal end of the syringe barrel and defining an outlet lumen that communicates with the syringe cavity, A syringe coupler, wherein the syringe coupler is A housing having a proximal axial end, a distal axial end and a central axis, A female first luer connector at the proximal shaft end of the housing, wherein the female first luer connector is coaxial with the central axis and has a first lumen defined therein, A male second Luer connector at the distal shaft end of the housing, wherein the male second Luer connector is coaxial with the central axis, and its male Luer tip has a second lumen defined therein that is in fluid communication with the first lumen, Includes a storage cap connected to the housing, covering the male second luer connector and sealing the second lumen, The female first luer connector of the housing is connected to the male barrel luer connector and delivers the flushing fluid held in the syringe cavity to the first and second lumens of the housing through the outlet lumen of the male barrel luer connector. The male second Luer connector of the housing is adapted to the connected insertion of the patient into the corresponding needleless IV connector, and delivers at least a portion of the flushing fluid held in the syringe cavity to the IV connector through the second lumen, and The syringe coupler is selectively detachable from the male barrel Luer connector, thereby enabling the male barrel Luer connector to be directly connected to the corresponding needleless IV connector, and delivering additional flushing fluid held in the syringe cavity to the IV connector. A flash syringe characterized by having the following features.

2. A flash syringe according to claim 1, further comprising a hollow sleeve held within the first lumen, wherein the proximal axial end of the hollow sleeve protrudes from the first lumen toward the proximal axial end of the housing and is inserted into the outlet of the male barrel Luer tip.

3. A flush syringe according to claim 1, wherein the storage cap further comprises a selectively removable flip cap connected to the distal end of the syringe coupler.

4. A flash syringe according to claim 3, further comprising a cap hinge connected to the flip cap and the coupler housing, wherein the cap hinge connects the flip cap to the coupler housing.

5. A flash syringe according to claim 1, further comprising: a circumferential cup protruding axially from the distal end of the housing and defining a distal axial surface; and a peel-off lid type storage cap connected to the distal axial surface of the circumferential cup and the second lumen.

6. A flash syringe according to claim 1, wherein the storage cap further comprises a selectively removable end cap assembly for preventing tampering.

7. A flush syringe according to claim 6, wherein the tamper-proof end cap assembly further comprises an end cap and a fragile tear ring connected to the end cap by at least one first cut-off connector and connected to the syringe coupler by at least one second cut-off connector.

8. A flush syringe according to claim 7, wherein the end cap assembly further comprises: a monolithic end cap assembly having a snap-on band surrounding the syringe coupler; a split tear ring incorporating a finger tab; a plurality of integrally formed first cut connectors connecting the end cap and the split tear ring; and a plurality of integrally formed second cut connectors connecting the split tear ring and the snap-on band.

9. A flash syringe according to claim 1, further comprising a twist-lock mechanism for connecting the proximal end of the housing to the barrel Luer connector, wherein the twist-lock mechanism, when engaged in a first position, prevents axial separation thereof, and when the female first Luer connector of the housing is removed from the male barrel Luer connector, disengages in a second position, which allows such axial separation.

10. The flash syringe according to claim 9, wherein the twist-lock mechanism further comprises A housing comprising a housing skirt defined between each of the first female and second male luer connectors, wherein the housing skirt surrounds the housing and the first female luer connector around the central axis and extends axially toward the proximal end of the housing, A skirt pin extending radially inward toward the central axis, A hollow connecting sleeve, the hollow connecting sleeve having a proximal end with an inner surface that firmly receives the outer circumferential surface of the male barrel luer connector therein, and a distal end with an outer surface that is received within the housing skirt and rotatable within the housing skirt, A cam slot formed on the outer surface of the distal end of the connecting sleeve, wherein the cam slot receives and captures the skirt pin, and the skirt pin is oriented to a first position within the cam slot when the first female luer connector and the barrel luer connector are fully tightened and in a fluid-seal engagement, and the skirt pin is oriented to a second position within the cam slot when the first female luer connector and the barrel luer connector are disconnected from each other, A flash syringe characterized by having the following features.

11. A flash syringe according to claim 10, further, A threaded barrel, a first female and a second male luer connector, The male barrel lure connector and the male second lure connector each have a threaded collar, wherein the threaded collar surrounds the respective male lure tip of the male barrel lure connector and the male second lure connector, A hollow connecting sleeve, wherein the hollow connecting sleeve is formed to securely receive the outer circumferential surface of the threaded collar of the corresponding male barrel luer connector, or to be integrally formed with the male barrel luer connector, A skirt pin, wherein the skirt pin is oriented to a first position within the cam slot when the first female luer connector and the barrel luer connector are fully screwed together, and the skirt pin is oriented to a second position when the first female luer connector and the barrel luer connector are fully unscrewed from each other, A claw oriented midway between the first and second positions within the cam slot, wherein the claw prevents the pin from unintentionally moving to the second position, A flash syringe characterized by having the following features.

12. A method for manufacturing a flash syringe, wherein the method is The invention provides a syringe barrel comprising a male barrel Luer connector oriented at the distal end of the syringe barrel, an open proximal end, and a syringe cavity within the barrel, wherein the barrel Luer connector has a male barrel Luer tip defining an outlet lumen communicating with the syringe cavity. The syringe coupler is to be prepared, and the syringe coupler is A housing having proximal and distal axial ends and a central axis, The female first luer connector at the proximal end of the housing, wherein the female first luer connector is coaxial with the central axis and has a first lumen defined therein, The syringe coupler is provided, comprising a male second Luer connector at the distal end of the housing, wherein the male second Luer connector is coaxial with the central axis and has a male Luer tip therein that has a second lumen that is in fluid communication with the first lumen, and the male second Luer connector is coaxial with the central axis. The female first lure connector is connected to the barrel lure connector, Connecting a selectively removable storage cap to the housing, wherein the storage cap covers the male second luer connector of the syringe coupler and seals the second lumen, and connecting the selectively removable storage cap to the housing, The syringe cavity is pre-filled with flushing fluid, A movable syringe plunger is inserted into the syringe cavity into the syringe barrel, A method for manufacturing a flash syringe, characterized by containing [the specified ingredient].

13. A method for manufacturing a flash syringe according to claim 12, further comprising: sterilizing the pre-filled flash syringe after insertion of the syringe plunger; and packaging the sterilized pre-filled flash syringe in a sterile packaging container.

14. A method for flushing a patient port during intravenous fluid administration to a patient by using the flush syringe described in claim 1, wherein the method is: Disinfect the hub of the patient port that has a hub connector, Remove the storage cap from the syringe coupler, Connecting the male second Luer connector of the syringe coupler to the Hub Luer connector of the patient port, By pushing down the syringe plunger, the first portion of the pre-filled flushing fluid held in the syringe cavity is distributed to the patient port through the male second Luer connector, The male second lure connector is to be separated from the hub lure connector, Disinfect the hub of the patient port, Using a drug administration syringe, one or more drugs are administered through the hub, and the hub is disinfected after the delivery of each drug. The female first Luer connector of the syringe coupler is disconnected from the male barrel Luer connector of the syringe, and then the syringe coupler is discarded. Disinfect the hub of the patient port, The male barrel Luer connector is connected to the hub Luer connector of the patient port, and the syringe plunger is pushed down to distribute the second portion of the pre-filled flushing fluid held in the syringe cavity to the patient port through the male barrel Luer connector. The procedure involves disconnecting the male barrel Luer connector from the hub Luer connector of the patient port, and then discarding the syringe. Disinfect the hub of the patient port, A method for flushing a patient port, comprising covering the hub of the patient port with a sterilized hub cap.

15. A method for flushing a patient port according to claim 14, further comprising: removing the flush syringe from the sterile packaging; and removing the storage cap from the male second Luer connector of the syringe coupler before connecting the syringe coupler to the Hub Luer connector.

16. A syringe coupler for intravenous fluid administration to a patient, wherein the syringe coupler is It is a syringe coupler, A housing having proximal and distal axial ends and a central axis, A female first luer connector at the proximal end of the housing, wherein the female first luer connector is coaxial with the central axis and has a first lumen defined therein, A syringe coupler comprising a male second Luer connector at the distal end of the housing, wherein the male second Luer connector has a second lumen defined therein, coaxial with the central axis, and having a male Luer tip that is in fluid communication with the first lumen, and the male second Luer connector having a second lumen. A storage cap connected to the housing, covering the male second luer connector and sealing the second lumen, The female first Luer connector of the housing is fitted to the connected receptacle of the male Luer tip of the Luer connector of the flash syringe, thereby enabling the outlet lumen formed in the male Luer tip of the syringe to fluidly communicate with the first and second lumens of the housing, and delivering the flushing fluid from the flash syringe through the second lumen. Syringe coupler comprising a male second Luer connector of the housing, the male second Luer connector being adapted for connected insertion into a corresponding needleless IV connector of a patient, and for delivering flushing fluid to the IV connector thereafter after the removal of the storage cap.

17. A syringe coupler according to claim 16, wherein the storage cap further comprises a selectively removable flip cap connected to the distal end of the syringe coupler.

18. A syringe coupler according to claim 16, further comprising: a circumferential cup protruding axially from the distal end of the housing and defining a distal axial surface; and a peel-off lid type storage cap connected to the distal axial surface of the circumferential cup and the second lumen.

19. A syringe coupler according to claim 16, wherein the storage cap further comprises a tamper-proof, selectively removable end cap assembly.

20. A syringe coupler according to claim 19, wherein the end cap assembly further comprises an end cap and a fragile tear ring connected to the end cap by at least one first cut-off connector and connected to the syringe coupler by at least one second cut-off connector.

21. A syringe coupler according to claim 20, wherein the end cap assembly further comprises A monolithic snap-on band surrounds the syringe coupler, A split slashing ring incorporating a finger tab, A plurality of integrally formed first cut-off connectors connect the end cap and the split cut-off ring, A syringe coupler characterized by comprising a plurality of integrally formed second cut-off connectors for connecting the split-off cut-off ring and the snap-on band.

22. A syringe coupler according to claim 16, further comprising a twistlock mechanism adapted to connect the proximal end of the housing to a barrel Luer connector of a flush syringe, wherein the twistlock mechanism, when engaged in a first position, prevents their axial separation, and when the female first Luer connector of the housing is removed from the male barrel Luer connector, disengages in a second position, which allows such axial separation.

23. A syringe coupler according to claim 22, wherein the twist lock mechanism further comprises The housing comprises a housing skirt defined between the first female and second male luer connectors, wherein the housing skirt extends axially toward the proximal end of the housing, surrounding the housing and the first female luer connector around the central axis, A skirt pin extending radially inward toward the central axis, A hollow connecting sleeve, the hollow connecting sleeve having a proximal end whose inner surface is fitted to firmly receive the outer surface of a male barrel luer connector therein, and a distal end whose outer surface is received within the housing skirt and is rotatable within the housing skirt, A syringe coupler comprising a cam slot formed on the outer surface of the distal end of the connecting sleeve, wherein the cam slot receives and captures the skirt pin, the skirt pin is oriented in the first position within the cam slot when the first female Luer connector and the barrel Luer connector are fully tightened into a fluid-seal engagement state, and the skirt pin is oriented in the second position within the cam slot when the first female Luer connector and the barrel Luer connector are disconnected from each other.

24. A syringe coupler according to claim 23, further comprising a claw oriented in the cam slot midway between the first and second positions to prevent the pin from moving unintentionally to the second position.

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