Repeated conveying and flushing injector

Abstract

Irrigation syringes with syringe couplers that facilitate double dispensing of intravenous irrigation solution to a patient's vascular access device (VAD) and reduce the risk of VAD infection. The syringe coupler is provided on its proximal end with a female first luer connector that is removably coupled to a male barrel luer connector of the syringe, isolating the latter connector from external contamination. The syringe coupler also has a single-use male second luer connector on a distal end of its housing, the male second luer connector adapted to be coupled into the VAD of the patient for delivery of at least a portion of the irrigation solution held within the syringe. After the first delivery, the syringe coupler is disengaged from both the VAD and the syringe. Thereafter, an unused, sterile male luer connector of the syringe is directly coupled to the VAD for dispensing a second portion of the flushing solution.

Description

Technical Field

[0001] In general, this disclosure relates to syringes for flushing a patient's vascular access device (VAD) (such as a patient access port). More specifically, this disclosure relates to a flushing syringe capable of dispensing a flushing solution to a patient's VAD in two separate flushing procedures (e.g., before and after drug administration), each using a novel sterile port connector, thereby reducing the potential risk of VAD infection. Background Technology

[0002] Vascular access devices (VADs) are commonly used therapeutic devices and include intravenous (IV) catheters. VADs are broadly classified into two categories: peripheral catheters and central venous catheters. Several types of access hubs, ports, or valves are attached to VADs when delivering fluids or medications. Some IV patient ports are opened by the truncated conical end of a syringe barrel (e.g., a Luer connector) to allow fluid communication between the syringe interior and the catheter. Luer connectors are a common way to connect or link syringes, catheters, hubed needles, IV tubing, etc., to each other. When VADs are used in medical patient care, there is a potential risk of clogging and component contamination.

[0003] Without proper maintenance, VADs can become clogged. To ensure proper VAD use and prevent clogging, standard practices have been established. These standards include cleaning procedures, often referred to as flushing procedures or catheter flushing. VAD practice standards typically recommend flushing procedures after catheter placement, before fluid infusion, and before and after medication administration, blood sampling, transfusions, and parenteral nutrition. The purpose of these flushing procedures is to confirm catheter patency, avoid drug incompatibilities, ensure complete drug dosage, prevent thrombosis, and minimize the risk of bloodstream infection. Flushing procedures require various types and volumes of flushing solutions. Commonly used flushing solutions are saline and / or heparin-locked solutions. The type and volume of flushing solution vary depending on the specific catheter type. Flushing solution volumes between 5 and 10 ml are most common, but can also range from 1 ml to 20 ml.

[0004] Flushing is also performed after medication administration because residual medication may remain in the Luer portion of the drug delivery syringe and in the catheter. Without a subsequent flushing procedure, the full dose of medication may not be delivered to the patient. Some medications are time-sensitive and should not be left in the catheter until a subsequent medication administration flushes away any residual medication from the previous administration. Therefore, a second flushing syringe is used for subsequent flushing to address residual medication delivery issues. Medication delivery and accompanying flushing via a VAD delivery system also inherently exposes the delivery system to potential contamination.

[0005] When delivering fluids or medications, bacteria and other microorganisms can enter a patient's vascular system from different types of patient connectors connected to the VAD. As a non-limiting example, connectors include access hubs, ports, or valves. Each patient connector, whether an access hub, port, valve, or other type of connection, is associated with some risk of catheter-related bloodstream infection (CRBSI), which can be costly and potentially fatal. To reduce CRBSI cases and ensure the proper use and maintenance of VADs, practice standards have been developed, including disinfection and cleaning procedures. Sterilization caps have been added to the guidelines of the Society for Health Care Epidemiology (SHEA), and caps are also included in the Infusion Nurse Standards (INS) guidelines.

[0006] In developed markets, when using IV catheters, needle-free patient connectors are typically used to seal the system and are then subsequently inserted to administer medications or other necessary fluids to the patient via the catheter. INS Practice Standards recommend the use of needle-free connectors and stipulate that they should be “consistently and thoroughly disinfected with alcohol, iodine, or a combination of chlorhexidine gluconate and alcohol before each insertion.” The ultimate goal of sterilizing needle-free connectors is to help reduce bacteria that can grow on the surface and may cause various catheter-related complications, including CRBSI. Nurses typically perform this sterilization task using a 70% isopropyl alcohol (IPA) pad through a process known as “scrubbing the hub.” Currently, many nursing units mandate scrubbing the patient’s IV connector hub, even if the connector is currently connected to an existing sterilization cap.

[0007] Typically, in a saline-drug-saline (SAS) workflow, administering a single medication via a VAD system requires four wiping procedures (usually performed with a sterile cap). The first sterile wipe prepares the patient's VAD connector for medication delivery and reception of the first flush syringe to confirm patency of the VAD delivery system and its IV catheter. After pre-flushing, the first flush syringe is removed. Subsequently, a second sterile wipe prepares the catheter hub for connection to the medication delivery syringe. A third sterile wipe prepares the catheter hub for connection to the second flush syringe to complete the flush following medication delivery. Finally, after removing the second flush syringe, a fourth sterile wipe is performed, followed by sealing the catheter hub with a cap or locking syringe. In cases of fluid-locked IV catheters other than saline (e.g., heparin) or saline-drug-saline-heparin (SASH) workflows, a third heparin flush procedure is required after the second saline flush, which necessitates a third flush syringe and a fifth sterile wipe. When administering more than one medication to a patient during the workflow, hub sterilization is performed after each additional medication dose before starting the next dispensing task.

[0008] Therefore, throughout the entire procedure necessary to prevent blockage within the VAD system and to administer medication to the patient, there is a risk of CRBSI contamination and microbial transmission each time the syringe is connected to or disconnected from the patient's VAD connector. Best IV catheter contamination practice prohibits the reuse of syringe connectors to patient port connectors.

[0009] Returning to the procedure for preparing the patient port for medication administration, after the initial IV port flushing, it is followed by flushing with a first sterile single-use flushing syringe. The practitioner then flushes the IV port again and administers a dose of medication fluid with a new sterile single-use medication syringe, followed by a post-administration flushing and rinsing with a second sterile single-use flushing syringe. In clinical practice, the initial IV port flushing, intravenous medication administration, and the second IV flushing after medication administration typically utilize three separate single-use syringes. The risk during medication administration is that the practitioner may reuse a contaminated single-use flushing syringe to perform pre- and post-administration flushing. Reusing a flushing syringe previously connected to the patient's IV port increases the risk of transmitting catheter-related bloodstream infection (CRBSI) to the patient.

[0010] However, it should be understood that reducing the number of syringes required for flushing and administering medications through a patient's IV port, while adhering to CRBSI reduction practices, is beneficial in many ways. Reduced syringe use, due to the fewer sterile syringe packages that need to be opened, reduces the time and effort required by clinicians; it also reduces syringe inventory and associated procurement and medical waste disposal costs. Summary of the Invention

[0011] The flushing syringe is equipped with a syringe connector that facilitates the dispensing of intravenous flushing solution to the patient's vascular access device (VAD) twice (e.g., before and after drug administration), while reducing the risk of VAD infection. The syringe embodiment of this disclosure connects to an unused sterile Luer connector for each of the two flushing procedures. The distal axial end of the syringe connector provides a first sterile Luer connector for coupling to a corresponding hub Luer connector of the VAD, and the distal end of the syringe connector establishes a sterile fluid seal with the corresponding barrel Luer connector of the syringe barrel.

[0012] When the syringe connector is removed / disconnected from the still sterile barrel Luer connector of the syringe, the barrel Luer connector directly connects to the now re-sterilized hub Luer connector of the VAD. More specifically, the syringe connector has a female first Luer connector on its proximal end, which is removably connected to the male barrel Luer connector of the syringe, isolating the male barrel Luer connector of the syringe and the flushing solution inside the syringe barrel from environmental contamination. A male second Luer connector on the distal end of the housing is adapted to connect to the VAD inserted into the patient for delivery of at least a portion of the flushing solution held within the syringe. Typically, after the first VAD flushing procedure, the clinician sterilizes the VAD and administers one or more medications to the patient through the VAD, sterilizing the VAD after each new medication administration. After the first flushing procedure, the syringe connector is disconnected from both the VAD and the male barrel Luer connector of the syringe. Thereafter, the unused sterile barrel Luer connector directly connects to the VAD for dispensing a second portion of the flushing solution. Each VAD connection of the syringe is performed using a new sterile connector. The VAD connector of the syringe must not be used twice. Therefore, a single IV flushing syringe can be used to perform both pre- and post-administration flushing of the patient's IV port. This can reduce the number of flushing syringes required to administer medication to the patient by 50% while still adhering to best CRBSI reduction practice standards. The reduction in syringe use also reduces associated syringe inventory and medical waste disposal costs. Some flushing syringe embodiments include an actuation indicator cap that visually identifies whether the first Luer connector has been previously used. Other flushing syringe embodiments include a twist-lock mechanism that passively separates the syringe connector from the syringe barrel upon initial use of the first Luer connector and after the first Luer connector has been removed from the VAD.

[0013] One aspect of this disclosure relates to a flushing syringe for administering intravenous fluid to a patient. In some embodiments, the syringe is pre-filled with a flushing solution and packaged in a sterile package. 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 translatable within the syringe cavity. A male Luer connector is oriented on the distal end of the syringe barrel; it has a male Luer tip defining an outlet lumen in communication with the syringe cavity. A syringe connector coupled to the syringe includes: a housing having a proximal axial end and a distal axial end, and a central axis; a female first Luer connector coaxial with the central axis is located on the proximal end of the housing; the first Luer connector has a first lumen defined therein. The syringe connector also has a male second Luer connector coaxial with the central axis on the distal end of the housing; it has a male Luer tip defining a second lumen. The first lumen and the second lumen are in fluid communication with each other. A reservoir cap is coupled to the housing, covering the male second Luer connector and sealing the second lumen. The female first Luer connector of the housing is adapted to be coupled to the male Luer connector for delivering flushing solution held in the syringe cavity through the outlet lumen of the male Luer connector to the first and second lumens of the housing. The male second Luer connector of the housing is adapted to be coupled to a corresponding needleless IV connector inserted into a patient or other type of VAD for delivering at least a portion of the flushing solution held in the syringe cavity to the IV connector. The syringe connector can be selectively removed from the male Luer connector, thereby allowing the male Luer connector to be directly coupled to the corresponding needleless IV connector for delivering additional flushing solution held in the syringe cavity to the IV connector.

[0014] Another aspect of this disclosure relates to a method for manufacturing the aforementioned flushing syringe. During this syringe manufacturing process, the syringe barrel is provided with a male Luer connector oriented at a distal end of the syringe barrel, an open proximal end, and a syringe cavity within the barrel. The syringe barrel Luer connector has a male Luer end that defines an outlet lumen communicating with the syringe cavity. A syringe connector is provided, comprising 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 and coaxial with the central axis, having a first lumen defined therein. A male second Luer connector is oriented at the distal end of the housing and coaxial with the central axis and has a male Luer end that defines a second lumen. The first lumen and the second lumen 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 reservoir cap is coupled to the housing, covering the male second Luer connector of the syringe connector and sealing the second lumen. In some embodiments, during syringe manufacturing, the syringe cavity is pre-filled with a flushing solution. Subsequently, a movable syringe plunger is inserted into the syringe barrel within the syringe cavity. In some embodiments, after inserting the syringe plunger, the assembled flushing syringe is sterilized and packaged in a sterile packaging container. In some embodiments, multiple flushing syringes are packaged in a shared sterile packaging container.

[0015] Several other aspects of this disclosure relate to a method of flushing a patient port during intravenous fluid administration using the aforementioned and described flushing syringe. When performing this flushing method, it is anticipated that the administering clinician will adhere to approved medical protocols to minimize the possibility of VAD contamination. The clinician sterilizes the hub of the patient port, which has a hub Luer connector or other VAD. After removing the flushing syringe from its sterile packaging and subsequently removing the storage cap from the syringe connector, the male second Luer connector of the syringe connector is engaged with the hub Luer connector of the patient port. By depressing the syringe plunger, a first portion of the pre-filled flushing solution held within the syringe cavity is dispensed into the patient port through the male second Luer connector of the syringe connector. The male second Luer connector disengages from the hub Luer connector, and the hub of the patient port is sterilized. Subsequently, one or more medications are administered through the hub using a drug-dosing syringe, and the hub is sterilized after each medication delivery. The syringe connector is disengaged from the syringe by disengaging the female first Luer connector from the male barrel Luer connector of the syringe. The syringe connector is then discarded. To prepare for the second VAD flushing procedure, the hub of the patient port is sterilized, and the male Luer connector is connected to the hub Luer connector of the patient port. A second portion of the pre-filled flushing solution held in the syringe chamber is dispensed into the patient port through the male Luer connector by depressing the syringe plunger. Afterward, the male Luer connector is disengaged from the hub Luer connector of the patient port, and the syringe is discarded. The hub of the patient port is sterilized again and covered with a sterile hub cap. Attached Figure Description

[0016] Exemplary embodiments of the present disclosure are further described in the following detailed description in conjunction with the accompanying drawings, wherein:

[0017] Figure 1 This is an isometric view of an embodiment of the flushing syringe of this disclosure;

[0018] Figure 2 yes Figure 1 The local axial cross-section of the syringe;

[0019] Figure 3 yes Figure 1 An isometric view of a syringe coupled to an exemplary needleless connector (NFC) patient port type VAD for the initial delivery of flushing solution to the VAD;

[0020] Figure 4 yes Figure 3 Enlarged axial cross-sectional view of the syringe connector / syringe and patient port;

[0021] Figure 5 yes Figure 3An isometric view of the syringe after the patient port has been flushed with a portion of the flushing solution previously contained in the syringe and after the syringe connector has been disengaged from both the patient port and the syringe barrel.

[0022] Figure 6 yes Figure 3 An isometric view of the syringe after its barrel Luer connector is directly attached to the patient port for a second flushing of the patient port with the remaining residual flushing solution in the syringe after the first flushing procedure.

[0023] Figure 7 This is a partial isometric elevation view of another embodiment of the flushing syringe of this disclosure, which has an actuation display peel cap;

[0024] Figure 8 yes Figure 7 A partial cross-sectional view of the flushing syringe;

[0025] Figure 9 This is an isometric view of another embodiment of the flushing syringe before its use display storage cap is removed and it is connected to the patient port;

[0026] Figure 10 yes Figure 9 A partial exploded elevation view of the flushing syringe;

[0027] Figure 11 yes Figure 9 A partial isometric view of the distal end of the flushing syringe;

[0028] Figure 12 yes Figure 9 A partial axial cross-sectional view of a flushing syringe shows an embodiment of a first end cap for sealing the second lumen of the syringe connector;

[0029] Figure 13 yes Figure 9 A partial axial cross-sectional view of a flushing syringe shows an embodiment of a second end cap for sealing the second lumen of the syringe connector;

[0030] Figure 14 yes Figure 9 A partial isometric view of the flushing syringe after removing the fragile, tear-off ring;

[0031] Figure 15 yes Figure 9 A partial isometric view of the flushing syringe after removing the active display, fragile, tear-off ring and attaching its syringe connector to the patient port;

[0032] Figure 16 After removing the syringe connector from the syringe Figure 9A partial isometric view of the flushing syringe;

[0033] Figure 17 yes Figure 9 An isometric view of the syringe after its barrel Luer connector is directly attached to the patient port for a second flushing of the patient port with the remaining residual flushing solution in the syringe after the first flushing procedure.

[0034] Figure 18 This is an isometric view of another embodiment of the flushing syringe disclosed herein, which has a twist-lock mechanism for passively separating its syringe connector from its syringe barrel;

[0035] Figure 19 yes Figure 18 A partial isometric view of the distal end of the flushing syringe;

[0036] Figure 20 yes Figure 18 A partial axial cross-sectional view of the flushing syringe;

[0037] Figure 21 yes Figure 18 A magnified layered view of the distal end of the flushing syringe before its storage cap is removed and its syringe connector is attached to the patient's VAD;

[0038] Figure 22 yes Figure 18 A magnified layered view of the distal end of the flushing syringe during the disassembly of its syringe connector from the syringe barrel Luer connector.

[0039] For ease of understanding, the same reference numerals are used where possible to indicate common elements in all figures. The figures are not drawn to scale. Detailed Implementation

[0040] Many aspects of the flushing syringe embodiments disclosed herein facilitate the separate dispensing and delivery of intravenous flushing solution contained within the flushing syringe to the patient's vascular access device (VAD) twice, reducing the risk of VAD contamination. Each of the two separate connections between the syringe and the VAD is accomplished using a new, sterile VAD connector. It is possible to dispense uncontaminated flushing solution twice, separately, to the patient's VAD before and after medication administration because the flushing syringe disclosed herein has two separate, sterilized Luer connectors for coupling to the hub connector of the VAD. In this way, the clinician has the ability to first flush the patient's VAD through the male Luer connector on the distal end of the syringe connector, which is oriented between and in fluid communication with both the VAD and the flushing solution contained within the flushing syringe. The syringe connector has a female Luer connector on its proximal end, which is removably coupled to the male Luer connector of the syringe barrel, isolating the male Luer connector of the syringe and the flushing solution within the syringe barrel from environmental contamination. After the initial flushing procedure, the male Luer connector of the syringe connector is disengaged from the patient's VAD. Typically, after the first VAD flushing procedure, the clinician disinfects the VAD and administers one or more medications to the patient through it, disinfecting the VAD after each new medication administration. After medication administration is complete, the female Luer connector of the syringe connector disengages from the uncontaminated male Luer barrel connector of the syringe. Thereafter, the uncontaminated barrel Luer connector is directly coupled to the VAD for dispensing a second portion of the flushing solution. Some embodiments disclosed herein include an actuation display cap to provide the clinician with a visual indication of whether the syringe connector has been previously used. Other embodiments include a twist-lock mechanism that passively separates the syringe connector from the syringe barrel when the male second Luer connector is disengaged from the patient port, preventing the syringe connector from being reused. Other embodiments include both an actuation display cap and a twist-lock mechanism.

[0041] In this disclosure, following convention, the distal end of the device is closest to the patient, for example, the end used to deliver one or more drugs to the patient, while the proximal end of the device is furthest from the patient and closest to the clinician or other medical practitioner. The following definitions are provided for the terminology used in this disclosure.

[0042] As used in this article, the use of “one,” “an,” and “the” includes both singular and plural forms.

[0043] As used herein, the term "Luer connector" refers to a connecting collar that is a standard method for attaching syringes, catheters, hubed needles, IV tubing, etc., to each other. A Luer connector consists of male and female interlocking tubes that are slightly tapered to ensure better hold together even with simple pressure / torsion mating. Optionally, Luer connectors may include additional threaded outer edges for added security. The male end of the Luer connector is associated with a flushing syringe and interlocks and connects with the female end located on a vascular access device (VAD). The Luer connector also has a distal end channel that releasably attaches the Luer connector to the hub of the VAD, and a proximal end channel that releasably attaches the Luer connector to the barrel of the syringe.

[0044] As used herein, ISO 80369-7:2016 defines the specifications of standard Luer connectors, including a 6% taper between the distal and proximal ends. Male standard Luer connectors increase in size from the open distal end to the proximal end. Female standard Luer connectors decrease in size from the open proximal end to the distal end. According to ISO 80369-7:2016, the outer cross-sectional diameter of a male standard Luer connector, measured 0.75 mm from the distal end, is between 3.970 mm and 4.072 mm. The length of the male standard Luer taper is between 7.500 mm and 10.500 mm. The outer cross-sectional diameter, measured 7.500 mm from the distal end, is between 4.376 mm and 4.476 mm. As used herein, the phrases “male standard Luer connector” and “female standard Luer connector” refer to connectors having the dimensions described in ISO 80369-7, the entire contents of which are incorporated herein by reference in their entirety.

[0045] As will readily be appreciated by those skilled in the art, although descriptive terms such as “end,” “hub,” “thread,” “protrusion / insert,” “plate,” “ramp,” “wall,” “top,” “side,” and “bottom” are used in this specification for ease of understanding, this is not intended to limit any component that may be used in combination or alone or that requires a specific spatial orientation to realize various aspects of the embodiments of this disclosure.

[0046] Before describing several exemplary embodiments of this disclosure, it should be understood that this disclosure is not limited to the details of the structures or process steps described below. This disclosure is capable of other embodiments and can be practiced or implemented in many ways.

[0047] The examples illustrated in this description are intended to aid in a comprehensive understanding of the exemplary embodiments of this disclosure. Therefore, those skilled in the art will recognize that various changes and modifications can be made to the embodiments described herein without departing from the scope and spirit of this disclosure. Furthermore, for clarity and brevity, descriptions of well-known functions and constructions have been omitted.

[0048] In exemplary 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 all combinations of other features to enable it to mate with a corresponding thread or threads of a corresponding connector.

[0049] According to a further exemplary embodiment of the present disclosure, the configuration of the structural elements constituting the pinless connector includes a collar protruding from the distal end of the cylinder, the collar including at least one thread for connection to a corresponding thread or plurality of threads of a corresponding connector.

[0050] According to a further exemplary embodiment of the present disclosure, the collar or pinless connector bends or elastically deforms to allow for better interference fit compliance with the corresponding connector.

[0051] According to a further exemplary embodiment of the present disclosure, a pinless connector may include: a female thread, the size and thread pattern of which are designed to engage with a standard ISO 594-2 type male fitting; and / or a male thread, the size and thread pattern of which are designed to engage with a standard ISO 594-2 type female fitting. An example of an ISO 594-2 type fitting is a type Q fitting.

[0052] In one or more embodiments, the female connector may be selected from the group consisting essentially of: needle connectors (for direct injection into a patient or insertion into a vial to aspirate a drug dose), needle-free connectors, catheter Luer connectors, stopcock valves, and hemodialysis connectors. In one or more embodiments, the needle-free connector is selected from Q-Syte 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, etc.

[0053] In one or more embodiments, the male connector may be an end of an intravenous fitting or a stopcock.

[0054] Now referring to the attached diagram, in Figures 1 to 6 The first aspect of this disclosure is illustrated, wherein a flushing syringe 30, now removed from its sterile packaging 31, includes a syringe barrel 32 and a syringe plunger 38 held within an internal syringe cavity 40, the syringe barrel 32 defining a distal end 34 and an open proximal end 36. In some embodiments, the syringe cavity 40 is pre-filled with a flushing solution 42 during syringe manufacturing. In some embodiments, the volume of the flushing solution 42 held within the syringe cavity 40 is 10 ml. The distal end 34 of the conical profile of the syringe barrel 32 is provided with a threaded male Luer connector 44, which connects to a syringe connector 46. The Luer connector 44 includes a male Luer end 50 having a tapered outer circumferential surface 51 terminating at a distal end surface 52. An outlet lumen 54 formed in the distal end surface 52 of the Luer end 50 is in fluid communication with the syringe cavity 28. The threaded male Luer connector 44 has a collar 48 having at least one inwardly facing thread 56 surrounding the Luer end 50. The syringe plunger 38 moves forward in the direction of arrow D to dispense flushing solution 42 under pressure from syringe cavity 40 through outlet lumen 54 of tube Luer connector 44.

[0055] As noted, in some embodiments, such as Figure 1 The flushing syringe 30 has a syringe chamber 40 pre-filled with flushing solution 42, wherein the proximal axial end of the syringe connector 46 is coupled 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 connector to retain the flushing solution within the syringe. Typically, the assembled, pre-filled flushing syringe 30, syringe connector 46, and flip cap 80 are pre-packaged in a sterile package 31. In some embodiments, multiple flushing syringes 30 are packaged separately in a shared sterile packaging container. An exemplary flushing syringe is shown and described in U.S. Patent No. 8,632,521,B2 entitled “Syringe Assembly,” the entire contents of which are incorporated by reference in all legal jurisdictions where such incorporation is permitted under patent law.

[0056] More specifically, refer to the cross-section Figure 2 and Figure 4The syringe connector 46 includes a housing 58 having a proximal axial end 60 and a distal axial end 62. The housing 58 defines a central axis. A threaded female first Luer connector 64 on the proximal end 60 of the housing 58 is oriented coaxially with the central axis and defines a female Luer tapered surface 65 and an external thread 66 terminating at the proximal end surface 67. The external thread 66 of the female first Luer connector 64 engages with a corresponding inwardly facing thread 56 formed within a collar 48 of the male barrel Luer connector 44. A first lumen 68 of the female first Luer connector 64 has an inlet 70 formed in a seating surface 71 of the housing 58. The first lumen 68 is in fluid communication with an outlet lumen 54 of the barrel Luer connector 44. A threaded male second Luer connector 72 on the distal end 62 of the housing 58 is oriented coaxially with the central axis and includes a tapered male Luer end 74. A second lumen 75 is formed within the male Luer end 74 and is in fluid communication with a first lumen 68 that is commonly connected to the female first Luer connector 64. The male second Luer connector 72 is provided with a collar 76 that defines at least one inwardly oriented thread 78.

[0057] Now for reference Figures 1 to 3 The storage or end cap of the syringe connector 46 is a flip cap 80, which has an outer distal end surface 82, an inner surface 84, and a circumferential wall 86. When the flip cap 80 covers the distal end 62 of the housing 58 of the syringe connector 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 the flushing solution 42 from leaking out of the syringe. The closed flip cap 80 also maintains the sterility of the male second Luer connector 72. A lifting tab 90 facilitates the separation of the flip cap 80 from the syringe connector 46, thereby exposing the male second Luer connector, such as... Figure 3 As shown in the diagram. In some embodiments, display tape or shrink seals are applied to the flip cap 80 and housing 58 to provide a visual indication to the clinician whether the syringe 30 has been previously used. A cap hinge 92 is coupled to the flip cap 80 and housing 58 for securing the flip cap to the connector housing. The cap hinge 92 is integrally formed with the housing 58 and flip cap 80; in other embodiments, one or more of these components are manufactured separately and coupled together.

[0058] Figure 3 and Figure 4The connection of the male second Luer connector 72 of the syringe connector 46 to a patient port (such as a needleless connection (NFC) type patient port 94) is depicted. The patient port 94 has a patient IV catheter 96, a hub 98, and a threaded female hub Luer connector 100 with external threads 102. At least one inwardly oriented thread 78 formed in the collar 76 of the male second Luer connector 72 engages the external threads 102 of the female hub Luer connector 100. During SASH administration, after an initial flushing of the patient port 94 with the flushing syringe 30, the syringe connector 46 is unscrewed from the patient port and subsequently from the syringe barrel Luer connector 44. Figure 5 After applying the medication and disinfecting the patient port 94, the tube Luer connector 44 is directly attached to the patient port for subsequent rinsing. Figure 6 ). Figure 2 and Figure 4 The male second Luer connector 72 and the male cylindrical Luer connector 44 have a compatible construction; either of these male connectors can be intentionally connected to a patient port (such as...). Figure 3 , Figure 4 and Figure 6 The corresponding hub Luer connector for the NFC-type patient port 94 is used for flushing the port.

[0059] The flushing fluid path established within the syringe connector 46 allows the flushing solution to be delivered to the patient port, such as patient port 94, in the same manner as when directly connected to the syringe connector 44, when the patient port is connected to the second male Luer connector 72. Figures 1 to 6 In this embodiment, the first lumen 68 and the second lumen 75 of the syringe connector housing 58 are connected to form a common fluid path, the flow direction of which originates from the inlet 70 and the seating surface 71 of the female first Luer connector 64 of the housing 58 and exits from the distal end of the male Luer end 74 of the male second Luer connector 72. Typically, during the initial flushing through the male second Luer connector 72, 5 ml of flushing solution is dispensed from the syringe chamber 40 into the hub Luer connector 100, which is half the 10 ml capacity of the syringe chamber. After the syringe Luer connector 44 is connected to the hub Luer connector 100, the remaining flushing solution in the syringe chamber 40 is dispensed into the hub Luer connector.

[0060] Figure 7 and Figure 8Another embodiment of the flushing syringe 103 is depicted, which has a syringe connector 104 provided with a release cap 126 type storage or end cap for covering and sealing its distal end. The release cap 126 advantageously provides a clinician with an operational visual indicator regarding whether the sterility of the syringe connector 140 has been compromised. The syringe connector 104 has a housing 106 having a first female Luer connector 108 and a second male Luer connector 110 with a male Luer end 111. The seating surface 112 of the housing 106 defines a first lumen 114 of the first female Luer connector 108. The male Luer end of the second male Luer connector 110 defines a second lumen 115. The first lumen 114 and the second lumen 115 of the syringe connector housing 106 are connected to form a common fluid path, the flow direction of which originates from the seating surface 112 of the female first Luer connector 108 and exits from the distal end of the male Luer end 111 of the male second Luer connector 110. A hollow sleeve 116 is held within the common fluid path formed by the connected first lumen 114 and the second lumen 115 of the housing 106. 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 syringe Luer connector 50. In some embodiments, inserting the hollow sleeve 116 into the outlet lumen 54 effectively isolates the outlet of the syringe Luer connector 44 and the syringe cavity 40 from external contamination. By inserting the proximal axial end of the hollow sleeve 116 into the outlet lumen 54, a flow channel or path is created for conveying the flushing solution 42 held within the syringe chamber 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 connector 104, the corresponding Luer connectors 108 and 110 and their internal fluid passage connections are constructed identically to those of the syringe connector 46.

[0061] The distal end of the housing 106 of the flushing syringe 103 includes a circumferential cup 120 that projects radially away from the central axis of the housing and axially away from the distal end of the housing. The circumferential cup 120 defines a distal axial surface 122 that, together with the distal end surface 124 of the male second Luer connector 110, is covered by a peel cap 126. In one or more embodiments, the peel cap 126 is a peelable seal comprising a peelable top of aluminum or a multilayer polymer film. The peel cap 126 includes a distal outer surface 128 and a proximal inner surface 130, which is coupled to or otherwise adhered to the distal axial surface 122 of the circumferential cup 120 and the distal end surface 124 of the male second Luer connector. The sealing composition of the release cap 126 provides a sufficient environmental seal between the aluminum or polymer film on its proximal inner surface 130 and the opposing distal axial surface 122 of the circumferential cup 120 and the opposing distal end surface 124 of the male second Luer connector 110, under the anticipated temperature, pressure, and humidity levels within a medical treatment facility. In some embodiments, the release cap 126 is heat-sealed or inductively sealed to the circumferential cup 120 together with the opposing distal end surface 124 of the male second Luer connector 110. In other embodiments, the release cap 126 is sealed to the circumferential cup 120 together with the opposing, connected distal end surface 124 of the male second Luer connector 110 using a pressure-sensitive or heat-sensitive adhesive. The adhered release cap 126 maintains the sterility of the male second Luer connector 110 and prevents leakage of rinsing solution from the second lumen 115 of the connector. The release tab 132 facilitates removal of the release cap 126 from the housing 106 to expose the male second Luer connector 110. In summary, the peel-off cap 126 minimizes the potential hazard of particle entry and also provides a substantially impermeable enclosure for the distal end of the housing 106, providing leak prevention and / or maintaining a sealed, sterile environment within the housing.

[0062] Figures 9 to 17 Another embodiment of the flushing syringe 138 is depicted, which has a syringe connector 140, the syringe connector 140 being provided with an operational display type storage or end cap assembly 150 for covering and sealing its distal end. The end cap assembly 150 advantageously provides a clinician with an operational display visual indicator regarding whether the sterility of the syringe connector 140 has been compromised. The syringe barrel 32, syringe plunger 37, and barrel Luer connector 44 of the flushing syringe 138 are similar to those previously described. Figures 1 to 8The syringe connector 140 is identical to those in embodiments 30 and 103. The syringe connector 140 includes a housing 142 with a female first Luer connector 144 at the proximal end of the housing, which connects to a tubular Luer connector 44. The housing 142 also includes a male second Luer connector 146 having a second lumen 148 for discharging flushing solution from the housing when connected to the patient port 94. In some embodiments, the syringe connector 140 is made of a transparent or colored polymer that allows visual inspection of its internal structure. In various embodiments, the internal structure and fluid flow channels from the internal syringe cavity 40 through the syringe connector 140 into the patient port 94 are... Figures 1 to 8 The syringe connectors in embodiments 46 and 104 are the same.

[0063] In some embodiments, multiple syringe connectors 140 are connected and stacked in series to facilitate more than two flushing procedures from the same syringe barrel 32. In use, the distal syringe connector 140 is connected to the patient port for the initial flushing procedure and is discarded when the procedure is completed. The next available distal syringe connector 140 in the stack is used to perform a second flushing procedure, etc.

[0064] One embodiment of the display end cap assembly 150 includes an end cap embodiment 152 that covers a male second Luer connector 146 and its second lumen 148, a snap-fit ​​band 154, and an open-loop tear-off ring 156. The snap-fit ​​band 154 snaps onto and rigidly engages with the outer circumferential surface of the syringe connector 140. The tear-off ring has finger-like tabs 158 at one end of its open-loop structure. In this embodiment, the end cap assembly 150 is an integral polymer structure formed by injection molding, wherein a plurality of integrally formed first shear connectors 160 connect the end cap 152 and the tear-off ring 156, and a plurality of integrally formed second shear connectors 161 connect the tear-off ring to the snap-fit ​​band 154. Figure 11 As indicated by the double arrows, separating the finger-shaped tab end of the tear-off ring from its opposite open end will destroy both of the multiple shear connectors 160 and 161, thereby allowing the removal of the end cap 152.

[0065] like Figure 12 As shown, in end cap assembly embodiment 150, the inner surface 162 of the axial wall of end cap embodiment 152 defines a male bump 164. When end cap embodiment 152 covers the male second Luer connector 146, the male bump 164 seals the second lumen 148 within the male Luer end 166 to prevent fluid leakage and maintain the sterility of the covered Luer connector. Figure 13The alternative end cap assembly 168 shown also seals the male Luer end 166. In this alternative embodiment, the end cap 170 has an inner axial wall surface 172 defining a circumferential collar 174 that seals against the corresponding outer circumferential surface of the male Luer end 166.

[0066] In other embodiments, the use of the display cap structure includes a shrink-wrap plastic film covering the cap, or a series of perforations, or a thinner-walled construction, or another type of fragile joint connecting the cap and the snap fastener. In some embodiments, the snap fastener is integrally formed within the housing 142. In some embodiments, the snap fastener 154 has a contrasting visual color (e.g., red) to alert the clinician that the cap 152 or 170 embodiment has been removed from the syringe connector 140 and that its corresponding male second Luer connector 146 may not be sterile.

[0067] The use of the flushing syringe 138 embodiment is as follows, refer to in sequence. Figure 11 and Figures 14 to 17 For the sake of brevity, the SASH hub scrubbing procedure followed during the use of the flushing syringe 138 is not described. The clinician prepares the flushing syringe 138 by peeling off the finger-like protrusions 158 of the tear-off ring 156 away from the syringe connector 140; this tears the corresponding shear connectors 160 and 161 (…). Figure 11 The tear-off ring 156 can be separated from the buckle strap 154 ​​and the end cap 152. Figure 14 The syringe connector 140 is connected to the patient port 94 to achieve the first flushing of the port. Figure 15 After the first flushing procedure is completed, the syringe connector 140 is disengaged from the patient port and the tubular Luer connector 44, and is subsequently discarded. Figure 16 After the medication is administered to the patient, the tube lure connector 44 is directly connected to the patient port 94, which allows for the administration of a second flushing procedure. Figure 17 ), such as regarding Figures 1 to 6 As described in embodiment 30 of the flushing syringe.

[0068] Figures 18 to 22Another embodiment of the flushing syringe 178 with a twist-lock mechanism is depicted, which prevents unintentional axial separation of the tubular Luer connector 44 from the syringe connector 180 when the twist-lock mechanism is engaged in a first position before the syringe connector is threaded into and connected to the patient port 94. Conversely, when the syringe connector 180 is loosened / disconnected from the patient port 94, the twist-lock mechanism passively disengages in a second position, facilitating the passive separation of the syringe connector 180 from the tubular Luer connector 44. By passively separating the syringe connector 180 from the tubular Luer connector 44 after removal from the patient port or other VAD, the syringe connector 180 cannot be unintentionally reused after its initial use with the first Luer connector.

[0069] like Figure 18 As shown, the flushing syringe 178 is attached to the patient port 94 by a relative clockwise rotation (double arrow T) and engages the twist-lock mechanism in its first position. When the flushing syringe 178 is removed from the patient port 94 by a relative counterclockwise rotation (double arrow R), it translates the twist-lock mechanism to its second position.

[0070] The syringe barrel 32, syringe plunger 37, and barrel Luer connector 44 of the flushing syringe 178 are as previously described. Figures 1 to 8 The syringes used in embodiments 30 and 103 are identical. The syringe connector 180 includes a housing 182 with a female first Luer connector 184 at its proximal end, which connects to the barrel Luer connector 44. The housing 182 also includes a male second Luer connector 186 for coupling to the patient port 94, a flip-cap type end cap or storage cap 188, and a flip-cap hinge 190. The structure, function, and operation of the flip-cap 188 and the flip-cap hinge 190 are the same as those in embodiments 30 and 103. Figures 1 to 6 The flip cap 80 and flip cap hinge 92 of the flushing syringe 30 are identical. In various embodiments, the internal structure and fluid flow channels from the internal syringe cavity 40 through the syringe connector 180 into the patient port 94 are... Figures 1 to 8 The syringe connectors in embodiments 46 and 104 are the same.

[0071] For more specific reference Figures 19 to 22The twist-lock mechanism includes a hollow connector sleeve 192 having a proximal end whose inner surface is rigidly located within the outer circumferential surface of the collar 48 of the male Luer connector 44. In this embodiment, the connector sleeve 192 is a separate component rigidly coupled to the Luer connector 44. In this way, the connector sleeve 192 allows the twist-lock mechanism to be incorporated into existing flushing syringes. In other embodiments, the connector sleeve 192 is integrally formed within the Luer connector 44. The twist-lock mechanism also includes a cup-shaped housing skirt 194 formed within a housing 182, positioned between the respective first female Luer connector 184 and the second male Luer connector 186. The housing skirt 194 surrounds the housing 182 and the first female Luer connector 184 about a central axis and extends axially toward the proximal end of the housing. The housing skirt 194 has an axial extension 196 that holds a skirt pin 198, which extends radially inward toward the central axis of the housing 182. The distal end 193 and outer surface of the connector sleeve 192 are received within the housing skirt 194 and are rotatable within the housing skirt 194.

[0072] When the syringe barrel 32 rotates relative to the housing 182 of the syringe connector 180, such as during the engagement or disengagement of the barrel Luer connector 44 with the female first Luer connector 184, the connector sleeve 192, rigidly connected to the barrel Luer connector, also rotates relative to the housing skirt. When the corresponding opposing threads of the barrel Luer connector 44 and the female first Luer connector 184 do not engage, the collar can axially separate from the housing 182 and the housing skirt 194. (Reference) Figure 21 and Figure 22 The axial separation and relative rotation between the connector sleeve 192 and the housing skirt 194 are constrained by the movement of the skirt pin 198, which is received in and can pass through a generally S-shaped cam groove 200 formed in the outer circumferential surface of the connector sleeve 192. Other flushing syringe embodiments are provided with multiple pairs of skirt pins 198 and cam grooves 200.

[0073] exist Figure 21 When the first female Luer connector 184 and the barrel Luer connector 44 are fully tightened into a fluid-sealed engagement (double arrow T), the skirt pin 198 is oriented in the previously described first position 202 within the cam groove 200. 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 between the housing 182 and the connector sleeve 192 / syringe. Figure 18 and Figure 22As shown, when the syringe connector 180 is unscrewed from the patient port 94 (double arrow R), the connector sleeve 192 also rotates in the same direction (double arrow I), causing the skirt pin 198 to travel along the cam groove 200 to its second position 204 after biasing the pawl 206 toward the housing skirt 194. The pawl 206 prevents the skirt pin 198 from unintentionally moving from the first position 202 into the second position 204. When the syringe connector 180 is fully unscrewed from both the patient port 94 and the syringe barrel 32, the axial retraction of the flushing syringe 30 (double arrow II) passively separates the syringe connector 180 from the patient port 94, but does not separate the syringe connector from the syringe barrel. This is because the skirt pin 198 is secured in the second position 204 to prevent complete axial separation of the syringe connector 180 and the flushing syringe 30. When it is desired to disengage the syringe connector 180 from the syringe barrel 32, the skirt pin 198 translates out of the cam groove 200 along the path indicated by the double arrow III. The disengaged flushing syringe 30 is now available for direct connection to the patient port 94 for administering a second-port flushing procedure, as per [reference needed]. Figures 1 to 6 The flushing syringe 30 is described in the embodiment.

[0074] Components of the flushing syringe embodiments 30, 103, 138, and 178, as well as other embodiments described herein, are constructed by injection molding or vacuum thermoforming. Exemplary materials used to construct the syringe connector and its end / storage cap include thermoplastic polymers. The hollow sleeve 116 is an elastomeric sleeve constructed by compression molding of a cross-linked rubber or thermoplastic elastomer material. Generally, components of the flushing syringe embodiments 30, 103, 138, and 178 are made of medical-grade plastic material types, such as polycarbonate, polypropylene, polyethylene, ethylene glycol-modified polyethylene terephthalate, acrylonitrile-butadiene-styrene, or any other moldable plastic material used in medical devices.

[0075] One or more embodiments of the flushing syringe described in this disclosure are manufactured in the following manner. In one exemplary manufacturing embodiment, reference is made to... Figures 1 to 6 A flushing syringe 30 is provided, which generally includes a syringe barrel 32 having a male Luer connector 44 oriented at a 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 Luer end 50 defining an outlet lumen 54 in communication with the syringe cavity 40. In some embodiments, an existing, readily available 10 ml capacity flushing syringe is used to manufacture the sequential delivery flushing syringe 30 of this disclosure.

[0076] The manufactured flushing syringe 30 embodiment includes a syringe connector 46 comprising a housing 58, as previously described, having axial ends 60 and 62 and a central axis; a female first Luer connector 64 at the proximal end of the housing, oriented coaxially with the central axis, having a first lumen 68 defined therein. The syringe connector 46 also includes a male second Luer connector 72 at the distal end of the housing, oriented coaxially with the central axis, having a second lumen 75 at its male Luer end 74. The first lumen 68 and the second lumen 75 are in fluid communication with each other. The female first Luer connector 64 is coupled to the barrel Luer connector 44. A storage cap or end cap (here, a flip-up cap 80) is coupled to the male second Luer connector 72 of the syringe connector 46. The syringe cavity 40 is pre-filled with flushing solution 42, and then the syringe plunger 38 is inserted into the syringe barrel 32 into the syringe cavity. In some embodiments, the completed pre-filled flushing syringe is sterilized and packaged in a sterile package 31. In some embodiments, a plurality of rinsing syringes 30 are packaged in a shared sterile packaging container.

[0077] In another exemplary manufacturing method, reference Figures 9 to 17 The flushing syringe 138 connects the integrally molded active display end cap assembly 150 to its syringe connector 140 by moving the snap-on strap 154 ​​forward over the housing 142. Other steps in manufacturing the flushing syringe 138 are the same as those in manufacturing the flushing syringe 30.

[0078] In another exemplary manufacturing method, reference Figures 18 to 22 The flushing syringe 178, before the syringe connector 180 is connected to the barrel Luer connector 44, has its connector sleeve 192 rigidly connected to the male barrel Luer connector 44. When the barrel Luer connector 44 is moved forward to axially align with and screw into the female first Luer connector 184, the axial extension 196 of the housing skirt 194 is biased outward away from the syringe connector 180, thereby disengaging the skirt pin 198 from contact with the connector sleeve 192. When the skirt pin 198 is radially aligned with the cam groove 200, the axial extension 196 is allowed to relax to its unbiased state, thereby orienting the skirt pin within the cam groove 200. The syringe barrel 32 is rotated counterclockwise to orient the skirt pin 198 into a first position 202 within the cam groove 200. The remaining steps for manufacturing the flushing syringe 138 are the same as those for manufacturing the flushing syringe 30.

[0079] Example

[0080] Example (a): A flushing syringe for administering intravenous fluid to a patient, comprising a syringe barrel having a distal end, an open proximal end, and a syringe cavity within the syringe barrel; a syringe plunger translatable within the syringe cavity; a male Luer connector oriented at the distal end of the syringe barrel and having a male Luer end defining an outlet lumen communicating with the syringe cavity; a syringe connector comprising a housing having a proximal axial end and a distal axial end, and a central axis; a female first Luer connector coaxial with the central axis at the proximal axial end of the housing, the female first Luer connector having a first lumen defined therein; and a male second Luer connector coaxial with the central axis at the distal end of the housing, the male Luer end of the male second Luer connector having a male Luer end. The device comprises: a second lumen defined therein in fluid communication with the first lumen; a storage cap coupled to the housing, covering the male second Luer connector and sealing the second lumen; the female first Luer connector of the housing coupled to the male Luer connector for delivering flushing solution held in the syringe cavity through the outlet lumen of the male Luer connector to the first and second lumens of the housing; the male second Luer connector of the housing adapted for coupling to a corresponding needleless IV connector for delivering at least a portion of the flushing solution held in the syringe cavity to the IV connector through the second lumen; and the syringe connector selectively removable from the male Luer connector, thereby allowing the male Luer connector to be directly coupled to the corresponding needleless IV connector for delivering additional flushing solution held in the syringe cavity to the IV connector.

[0081] Example (b): The flushing syringe according to Example (a) further includes a hollow sleeve held within the first lumen; the proximal axial end of the hollow sleeve extends from the first lumen toward the proximal axial end of the housing and is inserted into the outlet of the male tube Luer end.

[0082] Example (c): The flushing syringe according to Example (a) further includes a selectively removable flip cap coupled to the distal end of the syringe connector.

[0083] Example (d): The flushing syringe according to Example (c) further includes a cap hinge connected to the flip cap and the connector housing for fastening the flip cap to the connector housing.

[0084] Example (e): The flushing syringe according to Example (a) further includes a circumferential cup that protrudes axially away from the distal end of the housing, defining a distal axial surface; and a peel-off cap-type storage cap coupled to the distal axial surface of the circumferential cup and a second lumen.

[0085] Example (f): The flushing syringe according to Example (a) further includes a selectively removable operational display cap assembly.

[0086] Example (g): The flushing syringe according to Example (a) further includes: an end cap; a fragile tear-away ring connected to the end cap via at least one first shear connector and connected to the syringe connector via at least one second shear connector.

[0087] Example (h): According to the flushing syringe of Example (g), the end cap assembly further includes: an integral end cap assembly having a snap-fit ​​strap around the syringe connector; an open tear-off ring with finger-like protrusions; a plurality of integrally formed first shear connectors connecting the end cap and the open tear-off ring; and a plurality of integrally formed second shear connectors connecting the open tear-off ring and the snap-fit ​​strap.

[0088] Example (i): The flushing syringe according to Example (a) further includes a twist-locking mechanism that connects the proximal end of the housing to the barrel Luer connector, the twist-locking mechanism preventing axial separation when engaged in a first position, and disengaging in a second position when the female first Luer connector of the housing is removed from the male barrel Luer connector to allow such axial separation.

[0089] Example (j): According to the flushing syringe of Example (i), the twist-lock mechanism further includes the housing defining a housing skirt, the housing skirt being located between corresponding first female Luer connectors and second male Luer connectors, the housing skirt surrounding the housing and the first female Luer connector about the central axis and extending axially toward a proximal end of the housing; a skirt pin extending radially inward toward the central axis; and a hollow connector sleeve having a proximal end and a distal end, the inner surface of the proximal end rigidly receiving the male sleeve therein. The outer circumferential surface of the Luer connector, the outer surface of the distal end being received within the housing skirt and rotatable within the housing skirt; a cam groove formed in the outer surface of the distal end of the connector sleeve, the cam groove receiving and confining the skirt pin therein, the skirt pin being oriented in a first position within the cam groove when the first female Luer connector and the cylindrical Luer connector are fully tightened into a fluid-tight engagement, and the skirt pin being oriented in a second position within the cam groove when the first female Luer connector and the cylindrical Luer connector are disengaged.

[0090] Example (k): The flushing syringe of embodiment (j) further includes a threaded barrel, a first female Luer connector, and a second male Luer connector; the male barrel Luer connector and the second male Luer connector each have a threaded collar surrounding their respective male Luer ends; the hollow connector sleeve rigidly receives, or is integrally formed with, the outer circumferential surface of the external threaded collar of the corresponding male barrel Luer connector therein; the skirt pin is oriented in a first position within the cam groove when the first female Luer connector and the barrel Luer connector are fully screwed together, and is oriented in a second position when the first female Luer connector and the barrel Luer connector are fully screwed together; and a pawl oriented in the cam groove between the first position and the second position for preventing the pin from unintentionally moving to the second position.

[0091] Example (l): A method for manufacturing a flushing syringe, comprising providing a syringe barrel having a male Luer connector oriented at a distal end of the syringe barrel, an open proximal end, and a syringe cavity within the barrel, the Luer connector having a male Luer end defining an outlet lumen communicating with the syringe cavity; providing a syringe connector including a housing having a proximal axial end and a distal axial end, and a central axis; a female first Luer connector coaxial with the central axis at the proximal end of the housing, the female... A first Luer connector has a first lumen defined therein; a male second Luer connector, coaxial with the central axis, is located at the distal end of the housing, the male Luer end of the male second Luer connector having a second lumen defined therein in fluid communication with the first lumen; the female first Luer connector is coupled to the barrel Luer connector; a selectively removable storage cap is coupled to the housing, covering the male second Luer connector of the syringe connector and sealing the second lumen; the syringe cavity is pre-filled with a flushing solution; a translational syringe plunger is inserted into the syringe cavity into the syringe barrel.

[0092] Example (m): The method for manufacturing the flushing syringe according to Example (l) further includes sterilizing the pre-filled flushing syringe after inserting the syringe plunger; and packaging the now sterilized pre-filled flushing syringe in a sterile packaging container.

[0093] Example (n): A method of flushing a patient port during intravenous fluid administration using a flushing syringe according to Example (a), comprising: sterilizing the hub of the patient port having a hub Luer connector; removing the storage cap from the syringe connector; connecting the male second Luer connector of the syringe connector to the hub Luer connector of the patient port; dispensing a first portion of a pre-filled flushing solution held in the syringe cavity into the patient port through the male second Luer connector by depressing the syringe plunger; disengaging the male second Luer connector from the hub Luer connector; sterilizing the hub of the patient port; and administering one or more drugs through the hub using a drug-dosing syringe. After each medication is administered, the hub is sterilized; the female first Luer connector of the syringe connector is disconnected from the male Luer connector of the syringe, and then the syringe connector is discarded; the hub of the patient port is sterilized; the male Luer connector is connected to the hub Luer connector of the patient port, and a second portion of the pre-filled flushing solution held in the syringe cavity is dispensed into the patient port through the male Luer connector by pressing down the syringe plunger; the male Luer connector is disconnected from the hub Luer connector of the patient port, and then the syringe is discarded; the hub of the patient port is sterilized; and the hub of the patient port is covered with a sterilized hub cap.

[0094] Example (o): The method for flushing a patient port according to Example (n) further includes removing the flushing syringe from the sterile packaging and disengaging the storage cap from the male second Luer connector before connecting the male second Luer connector of the syringe connector to the hub Luer connector.

[0095] Example (p): A syringe connector for intravenous fluid administration to a patient, comprising a syringe connector including a housing having a proximal axial end and a distal axial end and a central axis; a female first Luer connector coaxial with the central axis at the proximal end of the housing, the female first Luer connector having a first lumen defined therein; a male second Luer connector coaxial with the central axis at the distal axial end of the housing, the male Luer end of the male second Luer connector having a second lumen defined therein in fluid communication with the first lumen; and a storage cap, the storage cap... A reservoir cap is coupled to the housing, covering the male second Luer connector and sealing the second lumen; the female first Luer connector of the housing is adapted to engage the male Luer end of a Luer connector receiving a flushing syringe, thereby forming an outlet lumen within the male Luer end of the syringe in fluid communication with a first lumen and a second lumen of the housing for delivering flushing solution from the flushing syringe through the second lumen; and the male second Luer connector of the housing is adapted to engage with a corresponding needleless IV connector inserted into a patient for delivering flushing solution from thereto into the IV connector after the reservoir cap is removed.

[0096] Example (q): According to the syringe connector of Example (p), the storage cap further includes a selectively removable flip cap coupled to the distal end of the syringe connector.

[0097] Example (r): The syringe connector according to Example (p) further includes a circumferential cup that protrudes axially away from the distal end of the housing, defining a distal axial surface; and a peel-off cap-type storage cap that is coupled to the distal axial surface of the circumferential cup and a second lumen.

[0098] Example(s): According to the syringe connector of Example(p), the storage cap further includes an operable display cap assembly that can be selectively removed.

[0099] Example (t): According to the syringe connector of Example (s), the end cap assembly further includes: an end cap; a fragile tearable ring connected to the end cap via at least one first shear connector and connected to the syringe connector via at least one second shear connector.

[0100] Example (u): According to the syringe connector of Example (t), the end cap assembly further includes an integral snap-fit ​​strap surrounding the syringe connector; an open tear-off ring with finger-like protrusions; a plurality of integrally formed first shear connectors connecting the end cap and the open tear-off ring; and a plurality of integrally formed second shear connectors connecting the open tear-off ring and the snap-fit ​​strap.

[0101] Example (v): The flushing syringe according to Example (p) further includes a twist-lock mechanism adapted to engage the proximal end of the housing to the barrel Luer connector of the flushing syringe, the twist-lock mechanism preventing axial separation when engaged in a first position and disengaging in a second position when the female first Luer connector of the housing is removed from the male barrel Luer connector to allow such axial separation.

[0102] Example (w): According to the syringe connector of Example (v), the torsion locking mechanism further includes the housing defining a housing skirt, the housing skirt being located between corresponding first female Luer connectors and second male Luer connectors, the housing skirt surrounding the housing and the first female Luer connector about the central axis and extending axially toward a proximal end of the housing; a skirt pin, the skirt pin extending radially inward toward the central axis; and a hollow connector sleeve having a proximal end and a distal end, the inner surface of the proximal end being adapted to rigidly receive the [unclear text - likely a syringe connector] therein. The outer circumferential surface of the male Luer connector, the outer surface of the distal end being received within the housing skirt and rotatable within the housing skirt; a cam groove formed in the outer surface of the distal end of the connector sleeve, the cam groove receiving and confining the skirt pin therein, the skirt pin being oriented in a first position within the cam groove when the first female Luer connector and the tube Luer connector are fully tightened into a fluid-tight engagement, and the skirt pin being oriented in a second position within the cam groove when the first female Luer connector and the tube Luer connector are disengaged.

[0103] Example (x): The syringe connector according to Example (w) further includes a pawl oriented in the cam groove between the first position and the second position to prevent the pin from unintentionally moving to the second position.

[0104] In this specification, the terms "one embodiment," "some embodiments," "various embodiments," "one or more embodiments," or "embodiment" refer to a specific feature, structure, material, or characteristic described in relation to that embodiment being included in at least one embodiment of this disclosure. Therefore, phrases such as "in one or more embodiments," "in some embodiments," "in various embodiments," "in one embodiment," or "in an embodiment" appearing throughout this specification do not necessarily refer to the same embodiment of this disclosure. Furthermore, specific features, structures, materials, or characteristics may be combined in any suitable manner in one or more embodiments. It will also be understood that the wording and terminology used herein are for descriptive purposes and should not be considered limiting. The terms "comprising," "including," or "having," and variations thereof, as used herein, mean to include the items listed herein and their equivalents, as well as additional items. Unless otherwise specified or limited, the terms "installation," "connection," "support," and "coupling," and variations thereof, are to be interpreted broadly; they cover direct and indirect installation, connection, support, and coupling. Furthermore, "connection" and "coupling" are not limited to physical, mechanical, or electrical connections or couplings.

[0105] Although the disclosure herein is provided with reference to embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of this disclosure. It will be apparent to those skilled in the art that various modifications and variations can be made to this disclosure without departing from the spirit and scope thereof. For example, the structural features and operation of specific syringe connector embodiments 46, 104, 140, and 180 have been described herein. Various male and female threaded Luer connectors have been described and integrated into the syringe barrel 32 and syringe connectors 46, 104, 140, and 180. In some embodiments, those Luer connectors are not threaded Luer connectors. Similarly, while the actuation display cap assembly 150 has been described as including a removable ring 156, other embodiments utilize other types of actuation display fittings. Other flushing embodiments feature passive separation of the actuation display cap structure and syringe connector from the syringe barrel structure disclosed herein. This disclosure is intended to include modifications and variations within the scope of the appended claims and their equivalents. The appended claims are not limited to the construction details and component arrangements of the exemplary embodiments set forth in the specification or shown in the drawings.

Claims

1. A flushing syringe for administering intravenous fluid to a patient, comprising: A syringe barrel having a distal end, an open proximal end, and a syringe cavity within the syringe barrel; A syringe plunger that is capable of translation within the syringe cavity; A male Luer connector, the male Luer connector being oriented on the distal end of the syringe barrel and having a male Luer end that defines an outlet lumen communicating with the syringe cavity; Syringe connector, comprising: A housing having a proximal axial end and a distal axial end, and a central axis; A female first Luer connector, coaxial with the central axis, is located at the proximal axial end of the housing, the female first Luer connector having a first lumen defined therein; A male second Luer connector, coaxial with the central axis, is located at the distal end of the housing. The male Luer end of the male second Luer connector has a second lumen defined therein that is in fluid communication with the first lumen. A storage cap, which is attached to the housing, covers the male second Luer connector, and seals the second cavity; The female first Luer connector of the housing is coupled to the male Luer connector for conveying the flushing solution held in the syringe cavity through the outlet lumen of the male Luer connector to the first and second cavities of the housing; The male second Luer connector of the housing is adapted to be coupled into a corresponding needleless intravenous connector for the patient, so as to deliver at least a portion of the flushing solution held in the syringe cavity to the intravenous connector through the second lumen; and The syringe connector can be selectively removed from the male Luer connector, thereby allowing the male Luer connector to be directly coupled to the corresponding needleless intravenous connector for delivering additional flushing solution held in the syringe cavity to the intravenous connector.

2. The flushing syringe according to claim 1, further comprising a hollow sleeve retained within the first lumen; the proximal axial end of the hollow sleeve extending from the first lumen toward the proximal axial end of the housing and inserted into the outlet of the male lumen's Luer end.

3. The flushing syringe of claim 1, wherein the storage cap further comprises a selectively removable flip cap coupled to the distal end of the syringe connector.

4. The flushing syringe of claim 3 further includes a cap hinge connected to the flip cap and the connector housing for fastening the flip cap to the connector housing.

5. The flushing syringe according to claim 1, further comprising: A circumferential cup that protrudes axially away from the distal end of the housing, defining a distal axial surface; And a peelable cap-type storage cap, which is connected to the distal axial surface of the circumferential cup and the second lumen.

6. The flushing syringe of claim 1, wherein the storage cap further comprises a selectively removable active display cap assembly.

7. The flushing syringe of claim 6, wherein the activated display cap assembly further comprises: Hat on; A fragile tearable ring is connected to the end cap via at least one first shear connector and to the syringe connector via at least one second shear connector.

8. The flushing syringe of claim 7, wherein the end cap assembly further comprises: An integral end cap assembly, the integral end cap assembly having: a snap-fit ​​strap surrounding the syringe connector; The ring has an opening with finger-like protrusions for tearing off; Multiple integrally formed first shear connectors, the first shear connectors connecting the end cap and the open tear-off ring; And multiple integrally formed second shear connectors, the second shear connectors connecting the open tear-off ring and the snap-on strap.

9. The flushing syringe of claim 1 further includes a twist-locking mechanism that engages the proximal end of the housing to the barrel Luer connector, the twist-locking mechanism preventing axial separation when engaged in a first position and disengaging in a second position when the female first Luer connector of the housing is removed from the male barrel Luer connector to allow such axial separation.

10. The flushing syringe according to claim 9, wherein the torsion lock mechanism further comprises: The housing defines a housing skirt located between a corresponding first female Luer connector and a second male Luer connector. The housing skirt surrounds the housing and the first female Luer connector about the central axis and extends axially toward the proximal end of the housing. Skirt pin, the skirt pin extending radially inward toward the central axis; A hollow connector sleeve having a proximal end and a distal end, wherein the inner surface of the proximal end of the hollow connector sleeve rigidly receives the outer circumferential surface of the male Luer connector therein, and the outer surface of the distal end of the hollow connector sleeve is received within the housing skirt and is rotatable within the housing skirt. A cam groove is formed on the outer surface of the distal end of the connector sleeve. The cam groove receives and confines the skirt pin therein. When the first female Luer connector and the tube Luer connector are fully tightened into a fluid-sealed engagement, the skirt pin is oriented in a first position within the cam groove. When the first female Luer connector and the tube Luer connector are disengaged, the skirt pin is oriented in a second position within the cam groove.

11. The flushing syringe of claim 10, further comprising: Threaded sleeve, first female Luer connector and second male Luer connector; The male Luer connector and the male second Luer connector each have a threaded collar surrounding the end of their respective male Luer connector; The hollow connector sleeve rigidly receives the outer circumferential surface of the external threaded collar of the corresponding male Luer connector, or is integrally formed with the male Luer connector; When the first female Luer connector and the cylindrical Luer connector are fully screwed together, the skirt pin is oriented in a first position within the cam groove; when the first female Luer connector and the cylindrical Luer connector are fully disengaged, the skirt pin is oriented in a second position; and A pawl, oriented within the cam groove between a first position and a second position, is used to prevent the pin from unintentionally moving to the second position.

12. A method for manufacturing a flushing syringe, comprising: A syringe barrel is provided having a male Luer connector oriented at a distal end of the syringe barrel, an open proximal end, and a syringe cavity within the barrel, the Luer connector having a male Luer end defining an outlet lumen in communication with the syringe cavity; A syringe connector is provided, the syringe connector comprising: A housing having a proximal axial end and a distal axial end, and a central axis; A female first Luer connector, coaxial with the central axis, is located at the proximal end of the housing, the female first Luer connector having a first lumen defined therein; A male second Luer connector, coaxial with the central axis, is located at the distal end of the housing. The male Luer end of the male second Luer connector has a second lumen defined therein that is in fluid communication with the first lumen. Connect the female first Luer connector to the cylindrical Luer connector; A selectively removable storage cap is attached to the housing, covering the male second Luer connector of the syringe connector and sealing the second lumen; The syringe cavity is pre-filled with a rinsing solution; The movable syringe plunger is inserted into the syringe chamber inside the syringe barrel.

13. The method for manufacturing a flushing syringe according to claim 12, further comprising: Sterilize the pre-filled flushing syringe after inserting the syringe plunger; And package the pre-filled sterilized flushing syringes in sterile packaging containers.

14. A method of flushing a patient's port during intravenous fluid administration using a flushing syringe according to claim 1, comprising: Disinfect the hub of the patient port with the hub Luer connector; Remove the storage cap from the syringe connector; Connect the male second Luer connector of the syringe connector to the hub Luer connector of the patient port; By depressing the syringe plunger, a first portion of the pre-filled flushing solution held in the syringe cavity is dispensed into the patient port via the male second Luer connector; Disconnect the second male Luer connector from the hub Luer connector; The hub of the patient's port is disinfected; One or more drugs are administered through the hub using a drug metering syringe, and the hub is sterilized after each drug is delivered; Disconnect the female first Luer connector of the syringe connector from the male Luer connector of the syringe, and then discard the syringe connector; The hub of the patient's port is disinfected; The male tube Luer connector is connected to the hub Luer connector of the patient port, and a second portion of the pre-filled flushing solution held in the syringe cavity is dispensed into the patient port through the male tube Luer connector by pressing down the syringe plunger; Disconnect the male Luer connector from the hub Luer connector at the patient port, and then discard the syringe; The hub of the patient's port is disinfected; as well as Cover the hub of the patient port with a sterilized hub cap.

15. The method for flushing a patient port according to claim 13, further comprising: Before connecting the male second Luer connector of the syringe connector to the hub Luer connector, remove the flushing syringe from the sterile packaging and detach the storage cap from the male second Luer connector.

16. A syringe connector for administering intravenous fluid to a patient, comprising: Syringe connector, the syringe connector comprising: A housing having a proximal axial end and a distal axial end, and a central axis; A female first Luer connector, coaxial with the central axis, is located at the proximal end of the housing, the female first Luer connector having a first lumen defined therein; A male second Luer connector, coaxial with the central axis, is located at the distal axial end of the housing. The male Luer end of the male second Luer connector has a second lumen defined therein that is in fluid communication with the first lumen. A storage cap, which is attached to the housing, covers the male second Luer connector, and seals the second cavity; The female first Luer connector of the housing is adapted to connect to the male Luer end of the Luer connector receiving the flushing syringe, thereby forming an outlet lumen within the male Luer end of the syringe in fluid communication with a first lumen and a second lumen of the housing for delivering flushing solution from the flushing syringe through the second lumen; and The male second Luer connector of the housing is adapted to be coupled into the corresponding needleless intravenous connector of the patient for delivering flushing solution from thereto into the intravenous connector after the storage cap has been removed.

17. The syringe connector of claim 16, wherein the storage cap further comprises a selectively removable flip cap coupled to a distal end of the syringe connector.

18. The syringe connector of claim 16, further comprising a circumferential cup projecting axially away from a distal end of the housing to define a distal axial surface; and a peel-off cap-type storage cap coupled to the distal axial surface of the circumferential cup and a second lumen.

19. The syringe connector of claim 16, wherein the storage cap further includes an operable display cap assembly that can be selectively removed.

20. The syringe connector of claim 19, wherein the active display cap assembly further comprises: Hat on; A fragile tearable ring is connected to the end cap via at least one first shear connector and to the syringe connector via at least one second shear connector.

21. The syringe connector of claim 20, wherein the end cap assembly further comprises: An integral buckle strap surrounds the syringe connector; The ring has an opening with finger-like protrusions for tearing off; Multiple integrally formed first shear connectors, the first shear connectors connecting the end cap and the open tear-off ring; and Multiple integrally formed second shear connectors connect the open tear-off ring and the buckle strap.

22. The syringe connector of claim 16 further includes a twist-lock mechanism adapted to engage the proximal end of the housing to a barrel Luer connector of a flushing syringe, the twist-lock mechanism preventing axial separation when engaged in a first position and disengaging in a second position when the female first Luer connector of the housing is removed from the male barrel Luer connector to allow such axial separation.

23. The syringe connector according to claim 22, wherein the torsion lock mechanism further comprises: The housing defines a housing skirt located between a corresponding first female Luer connector and a second male Luer connector. The housing skirt surrounds the housing and the first female Luer connector about the central axis and extends axially toward the proximal end of the housing. Skirt pin, the skirt pin extending radially inward toward the central axis; A hollow connector sleeve having a proximal end and a distal end, the inner surface of the proximal end of the hollow connector sleeve being adapted to rigidly receive the outer circumferential surface of the male Luer connector therein, and the outer surface of the distal end of the hollow connector sleeve being received within the housing skirt and rotatable within the housing skirt. A cam groove is formed in the outer surface of the distal end of the connector sleeve, the cam groove receiving and confining the skirt pin therein, the skirt pin being oriented in a first position within the cam groove when the first female Luer connector and the tube Luer connector are fully tightened into a fluid-sealed engagement, and the skirt pin being oriented in a second position within the cam groove when the first female Luer connector and the tube Luer connector are disengaged.

24. The syringe connector of claim 23 further includes a pawl oriented within the cam groove between a first position and a second position for preventing the pin from unintentionally moving to the second position.

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