EP-4735076-A1 - DEVICE FOR DISINFECTING AND FLUSHING AN INTRAVENOUS CONNECTOR

Abstract

A disinfection and flushing device for an intravenous patient connector requires only a single coupling of a disinfection cap of the device to the patient connector, both to scrub the patient connector and to administer flushing solution through the connector via a flush syringe that is already coupled to a housing portion of the device. The disinfection cap and housing portions of the device are coupled together during the initial patient connector scrub and flush operation. Thereafter, in some embodiments, the housing and its attached, spent flush syringe, are selectively separable from the disinfection cap portion of the device, so that the disinfection cap remains in place on the patient connector. In other embodiments, the entire device, including its cap, housing and the flush syringe that is coupled to the housing, are removed from the patient connector.

Inventors

• NALAWADE, Praveen
• PRASAD, Shishir
• YOUNG-STEWART, Joyce L.

Assignees

• Becton, Dickinson and Company

Dates

Publication Date

20260506

Application Date

20240625

Claims (1)

1. Docket #P-28746.WO01 PATENT What is claimed is: 1. A device for disinfecting and flushing of an intravenous patient connector, comprising: a guide housing having an internal, first, circumferential wall surface, a proximal end wall defining a first through aperture therein, a distal end wall defining second through aperture therein, and a first internal cavity defined within the first circumferential wall surface and the respective proximal and distal end walls; an end cap captured within and translatable within the first internal cavity, a proximal end of the end cap defining an inlet and a first Luer connector adapted for engagement, through the first through aperture, with a corresponding Luer tip of a flush syringe, a distal end of the end cap defining a shaft with an spiked tip, the shaft defining an outlet and an internal lumen in fluid communication with the inlet and the outlet of the end cap; a disinfection cap having an internal, second, circumferential wall surface, a proximal end wall defining a third through aperture for receipt of the shaft of the end cap, and a distal open end, the second circumferential wall surface defining a second Luer connector adapted for engagement with a corresponding Luer connector of a patient connector; the first internal cavity and a second internal cavity being aligned with each other so that the spiked tip of the end cap is translatable within the third through aperture into the second cavity; an elastomeric sleeve captured within the second internal cavity, the sleeve having a proximal surface that is pierced by the spiked tip when the end cap shaft is translated through the third through aperture, and a distal surface facing the open distal end of the disinfection cap; and a disinfection pad captured within the second internal cavity, intermediate the elastomeric sleeve and the distal open end of the disinfection cap, the pad defining a fourth aperture for exposure of the distal surface of the elastomeric sleeve to the distal open end of the disinfection cap, the disinfection pad defining a distal end surface Docket #P-28746.WO01 PATENT adapted for disinfection of the patient connector when the disinfection cap is coupled to a connector; wherein translation of the spiked tip of the end cap pierces the elastomeric sleeve and enables direct fluid communication between the inlet of the end cap and the distal open end of the disinfection cap. 2. The device of claim 1, further comprising a selectively engageable locking mechanism coupling the distal end wall of the guide housing to the proximal end wall of the disinfection cap. 3. The device of claim 2, further comprising the distal end wall of the guide housing and the proximal end wall of the disinfection cap nested and slidably engaged with each other, with selective engagement and separation thereof facilitated by engagement and disengagement of the locking mechanism. 4. The device of claim 3, the selectively engageable locking mechanism comprising a twist connector. 5. The device of claim 4, the twist connector comprising at least one bayonet pin formed on the guide housing or the disinfection cap and a corresponding receptor slot formed on the other of the guide housing or the disinfection cap. 6. The device of claim 5, the at least one receptor slot having a T-shaped profile or an L-shaped profile or a J-shaped profile. comprises a bayonet pin 124 on the disinfection cap 46 and a J-shaped receptor slot 150 formed in the guide housing. 7. The device of claim 1, the guide housing and the disinfection cap permanently coupled to each other. 8. The device of claim 1, the elastomeric sleeve having a peripheral flange abutting the proximal end wall of the disinfection cap and a hollow, tubular stem Docket #P-28746.WO01 PATENT portion projecting into the second cavity for receiving the shaft of the end cap, with a distal tip of the tubular stem pierceable by the spiked tip. 9. The device of claim 8, further comprising the tubular stem having expandable bellows configured to be axially expandable upon insertion of the shaft of the end cap therein. 10. The device of claim 1, further comprising the guide housing having a lid with a distal end thereof coupled to the housing and a proximal end thereof projecting axially away from the proximal end of the housing in a first position and displaced away from said proximal end of the housing in a second position, whereby when the lid is in its first position, it blocks advancement of the end cap within the first internal cavity of the guide housing, but allows said advancement when the lid is in its second position, said advancement enabling the spiked tip of the end cap to pierce the elastomeric sleeve. 11. The device of claim 1, further comprising a web peel lid covering the distal open end of the disinfection cap. 12. The device of claim 1, the disinfection pad further comprising an antimicrobial material. 13. The device of claim 12, wherein the disinfection pad is compressible upon affixation of the disinfection cap to a patient connector. 14. The device of claim 1, the first and/or the second Luer connector comprising a threaded Luer connector. 15. A system for disinfecting and flushing an intravenous patient connector, comprising: a guide housing having an internal, first, circumferential wall surface, a proximal end wall defining a first through aperture therein, a distal end wall defining second Docket #P-28746.WO01 PATENT through aperture therein, and a first internal cavity defined within the first circumferential wall surface and the respective proximal and distal end walls; an end cap captured within and translatable within the first internal cavity, a proximal end of the end cap defining an inlet and a first Luer connector, a distal end of the end cap defining a shaft with a spiked tip, the shaft defining an outlet and an internal lumen in fluid communication with the inlet and the outlet of the end cap; a disinfection cap having an internal, second, circumferential wall surface, a proximal end wall defining a third through aperture for receipt of the shaft of the end cap, and a distal open end, the second circumferential wall surface defining a second Luer connector; the respective first and second cavities being aligned with each so that the spiked tip of the end cap is translatable within the third through aperture into the second cavity; an elastomeric sleeve captured within the second internal cavity, the sleeve having a proximal surface that is pierced by the spiked tip when the end cap shaft is translated through the third through aperture, and a distal surface facing the open distal end of the disinfection cap; and a disinfection pad captured within the second internal cavity, intermediate the elastomeric sleeve and the distal open end of the disinfection cap, the pad defining a fourth aperture for exposure of the distal surface of the elastomeric sleeve to the distal open end of the disinfection cap, the disinfection pad defining a distal end surface; a pre-filled flush syringe having a syringe barrel containing a flushing solution, a translatable plunger within the syringe barrel, and a third Luer connector that is inserted through the first through aperture of the guide housing and coupled to the first Luer connector of the end cap, the inlet of the end cap in fluid communication with the flushing solution contained within the syringe barrel; and a patient connector including a connector body defining a fourth Luer connector coupled to the second Luer connector within the disinfection cap, with the distal end surface of the disinfection pad in contact with the fourth Luer connector; wherein advancement of the flush syringe into the first cavity translates the spiked tip of the end cap, piercing the elastomeric sleeve and enabling fluid Docket #P-28746.WO01 PATENT communication of the flushing solution between the flushing syringe and the patient connector, via the inlet, internal lumen and outlet of the end cap, and wherein advancement of the translatable plunger dispenses the flushing solution into the patient connector. 16. The system of claim 15, further comprising a selectively engageable locking mechanism coupling the distal end wall of the guide housing to the proximal end wall of the disinfection cap, for selective separation of the guide housing and flushing syringe from the disinfection cap. 17. The system of claim 16, the selectively engageable locking mechanism comprising a twist connector. 18. The system of claim 17, the twist connector comprising at least one bayonet pin formed on the guide housing or the disinfection cap and a corresponding receptor slot formed on the other of the guide housing or the disinfection cap. 19. The system of claim 18, the at least one receptor slot having a T-shaped profile or an L-shaped profile for facilitating selective separation of the guide housing and the flush syringe from the disinfection cap when the guide housing is twisted in a first direction relative to the disinfection cap and for removing the disinfection cap, along with the guide housing and the flush syringe from the patient connector when the guide housing is twisted in a second direction relative to the disinfection cap. 20. The system of claim 18, the at least one receptor slot having a J-shaped profile for selective separation of the guide housing and the flush syringe from the disinfection cap when the guide housing is twisted in a first direction relative to the disinfection cap, leaving the disinfection cap coupled to the patient connector. Docket #P-28746.WO01 PATENT 21. The system of claim 15, the guide housing and the disinfection cap permanently coupled to each other, so that disconnection of the disinfection cap from the patient connector separates the entire system from the patient connector. 22. The system of claim 15, further comprising the guide housing having a lid with a distal end thereof coupled to the housing and a proximal end thereof projecting axially away from the proximal end of the housing in a first position and displaced away from said proximal end of the housing in a second position, whereby when the lid is in its first position, it blocks advancement of the syringe and the coupled end cap within the first internal cavity of the guide housing, but allows said advancement when the lid is in its second position, said advancement enabling the spiked tip of the end cap to pierce the elastomeric sleeve. 24. The system of claim 15, further comprising a web peel lid covering the distal open end of the disinfection cap. 25. The system of claim 15, the disinfection pad further comprising an antimicrobial material. 26. The system of claim 25, further comprising a compressible disinfection pad that compresses upon affixation of the disinfection cap to a patient connector. 27. The system of claim 15, the corresponding pair of coupled first and third Luer connectors and/or the corresponding pair of coupled second and fourth Luer connectors comprising threaded Luer connectors.

Description

Docket #P-28746.WO01 PATENT DEVICE FOR DISINFECTING AND FLUSHING AN INTRAVENOUS CONNECTOR TECHNICAL FIELD [0001] The present disclosure generally relates to devices for disinfecting and flushing patient connectors used for intravenous (IV) administration of medication and other fluids to or from patients. More specifically, the present disclosure relates to a disinfection and flushing device that requires only one coupling to the patient connector. BACKGROUND [0002] Vascular access devices (VAD's) are commonly used therapeutic devices and include intravenous (IV) catheters. There are two general classifications of VAD's, peripheral catheters and central venous catheters. Several types of access hubs, ports or valves are coupled to a VAD when delivering a fluid or pharmaceutical. A Luer connector is a common way to couple or join syringes, catheters, hubbed needles, IV tubes, etc. to each other. When VADs are used for medical patient care, there are potential risks of occlusions and contamination of components. [0003] If not properly maintained, VADs can become occluded. To ensure VADs are used properly and do not become occluded, standards of practice have been developed. These standards include a cleaning procedure, which is commonly referred to as a flush procedure or flushing a catheter. VAD standards of practice usually recommend flush procedures be performed after catheter placement, before fluid infusion, and before and after drug administration, blood sampling, transfusions, and parenteral nutrition. The goal of these flush procedures is to confirm catheter patency, avoid drug incompatibilities, ensure the complete drug dose administration, prevent thrombus formation, and minimize the risk of blood stream infections. Flush procedures require diverse types and amounts of flush solutions. Commonly used flush solutions are saline and/or heparin lock solution. The type of flush solution and amount vary depending on the specific type of catheter. After flushing, the practitioner is then able to administer a dosage of medical fluid, followed by a post-administration Docket #P-28746.WO01 PATENT flushing. Medication delivery and companion flushing through VAD delivery systems also inherently expose the delivery system to potential contamination. [0004] Bacteria and other microorganisms may gain entry into a patient’s vascular system from diverse types of patient connectors, including by way of non-limiting example, access hubs, ports or valves, upon their connection to the VAD when delivering a fluid or pharmaceutical. Each patient connector, whether an access hub, port, valve or other type of connection, is associated with some risk of transmitting a catheter related bloodstream infection (CRBSI), which can be costly and potentially lethal. In order to decrease CRBSI cases and to ensure VAD's are used and maintained correctly, standards of practice have been developed, which include disinfecting and cleaning procedures. Disinfection caps have been added to the Society for Healthcare Epidemiology of America (SHEA) guidelines and caps are also incorporated into the Infusion Nurses Standards (INS) guidelines. [0005] In developed markets, when utilizing an IV catheter, a needleless patient connector will typically be used to close off the system and then subsequently be accessed to administer medication or other necessary fluids via the catheter to the patient. INS Standards of Practice recommend the use of a needleless connector and state that it should be "consistently and thoroughly disinfected using alcohol, tincture of iodine or chlorhexidine gluconate/alcohol combination prior to each access." The disinfection of the needleless connector is ultimately intended to aid in the reduction of bacteria that could be living on the surface and possibly lead to a variety of catheter related complications including CRBSI. Nurses will typically utilize a 70% isopropyl alcohol (IPA) pad to complete this disinfection task by doing what is known as "scrubbing the hub." Currently many nursing units mandate the practice of scrubbing the patient’s IV connector hub, even if the connector is presently coupled to an existing disinfection cap. [0006] Typically, four disinfection caps and four scrubbing procedures are required to administer a single drug through a VAD system in a Saline-Administration of drug- Saline (SAS) workflow process. The first disinfection scrub prepares the patient’s VAD connector for drug delivery and receipt of a first flushing syringe to dissolve potential occlusions within the VAD delivery system and its IV catheter. The first flushing Docket #P-28746.WO01 PATENT syringe is removed after completion of the pre-flush. Thereafter a second disinfection scrub prepares the catheter hub for connection to a medication delivery syringe. A third disinfection scrub prepares the catheter hub for connection of a second flushing syringe to complete a post-medication delivery flush. Lastly, after removal of th