Device for disinfecting and flushing intravenous connectors

Abstract

A disinfection and irrigation device for an intravenous patient connector only requires a single coupling of a disinfection cap of the device to the patient connector, both scrubbing of the patient connector and application of an irrigation solution through the connector via an irrigation syringe that has been coupled to a housing portion of the device. The disinfection cap and the housing portion of the device are coupled together during initial patient connector scrubbing and flushing operations. Thereafter, in some embodiments, the housing and its attached used irrigation syringe may be selectively separated from the sterilisation cap portion of the device such that the sterilisation cap remains in place on the patient connector. In other embodiments, removing the entire device from the patient connector includes a cap, a housing, and an irrigation syringe coupled to the housing.

Description

Technical Field

[0001] This disclosure generally relates to apparatus for disinfecting and rinsing a patient connector used to administer drugs and other fluids to or from a patient via intravenous (IV) administration. More specifically, this disclosure relates to a disinfection and rinsing apparatus that requires only a single connection to the patient connector. 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 connected to VADs when delivering fluids or medications. Luer connectors are a common way to connect or link syringes, catheters, hubed needles, IV tubing, etc. When VADs are used in medical patient care, there are potential risks of clogging and component contamination.

[0003] Without proper maintenance, VADs can become clogged. To ensure proper use of VADs 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, infusion, and parenteral nutrition administration. 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 normal saline and / or heparin-locked solutions. The type and volume of flushing solution vary depending on the specific catheter type. After flushing, the practitioner is then able to administer a dose of medical fluid, followed by post-administration flushing. Drug delivery and accompanying flushing via VAD delivery systems also inherently expose the delivery system to potential contamination.

[0004] When fluids or medications are delivered, bacteria and other microorganisms can enter a patient's vascular system through different types of patient connectors connected to a 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.

[0005] 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 “continuous and thorough disinfection should be performed before each insertion using alcohol, iodine, or a combination of chlorhexidine gluconate and alcohol.” The disinfection of needle-free connectors ultimately aims to help reduce bacteria that can grow on the surface and may lead to various catheter-related complications, including CRBSI. Nurses typically use a 70% isopropyl alcohol (IPA) pad to perform the disinfection task through what is known as “wiping the hub.” Currently, many nursing units mandate wiping the patient’s IV connector hub, even if the connector is currently connected to an existing sterilization cap.

[0006] Typically, in a saline-drug-saline (SAS) workflow, administering a single medication via a VAD system requires four sterile caps and four wiping procedures. The first sterile wiping prepares the patient's VAD connector for medication delivery and reception of the first flush syringe to dissolve any potential blockages within the VAD delivery system and its IV catheter. After pre-flushing, the first flush syringe is removed. Subsequently, a second sterile wiping prepares the catheter hub for connection to the medication delivery syringe. A third sterile wiping prepares the catheter hub for connection to the second flush syringe to complete the post-medication flush. Finally, after removing the second flush syringe, a fourth sterile wiping is performed, followed by sealing the catheter hub with a cap or locking syringe. In the case of a saline-drug-saline-heparin (SASH) workflow, a third heparin flush procedure is required after the second saline flush, which necessitates a third flush syringe and a fifth sterile wiping. 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.

[0007] Throughout the entire sequence of procedures necessary to prevent clogging within the VAD system and to administer medication to a patient, there is a risk of CRBSI contamination and microbial transmission each time a syringe connects to or disconnects from the patient's VAD connector. It is desirable to minimize the number of VAD connections and disconnections required to administer one or more medications to a patient, as well as the number of VAD wiping procedures required to administer medications to a patient via a VAD hub or other device, in order to reduce the risk of contamination. Reducing the number of VAD connections and disconnections will beneficially save clinicians time and reduce the number of syringes and sterilization caps required to administer one or more medications to a patient. Summary of the Invention

[0008] The disinfection and rinsing device of this disclosure requires only a single connection of the device's disinfection cap to the IV patient connector to clean the patient connector and apply rinsing solution through the connector via a rinsing syringe already connected to the housing portion of the device. During the initial patient connector cleaning and rinsing operation, the disinfection cap and the housing portion of the device are engaged together. Subsequently, in some embodiments, the housing and its attached used rinsing syringe can be selectively separated from the device's disinfection cap portion, such that the disinfection cap remains in place on the patient connector, thereby sealing the connector.

[0009] The disclosed device's single-connection to the patient connector ensures a passive connector scrubbing action, conforming to the US Society for Health Care Epidemiology (SHEA) and Infusion Nurse Standards (INS) guidelines, followed by IV line flushing. The disclosed device enhances adherence to nursing disinfection guidelines by reducing touch contamination through aseptic, touchless, passive scrubbing techniques, reducing microbial growth against those microorganisms typically associated with CRBSI, and streamlining workflows. By incorporating passive scrubbing and disinfection capabilities within the device's sterilization cap, clinicians will not need to remember whether the patient connector / hub was scrubbed before connecting the flushing syringe to the IV connector, midway through the flushing fluid flow path from the syringe to the patient connector. Subsequently, if the disclosed device is used only for intermittent flushing prior to administering medication or other fluids through the patient connector, the sterilization cap is selectively removed to allow medication infusion through the patient connector. Alternatively, if the disclosed device is used for final patient connector flushing after medication administration, the housing and flushing syringe are detached from the sterilization cap, leaving the cap in place on the patient connector. In practice, when performing the SAS workflow, one or more medications can be administered through the patient connector using only two devices of this disclosure. The first device scrubs and rinses the patient connector; then one or more medications are administered through the now-scrubbed / rinsed patient connector. Subsequently, the second device performs a final scrub and rinse, leaving its sterile cap in place on the patient connector. The SASH workflow requires a third of the sterilization / rinsing devices of this disclosure to perform a final heparin rinse of the patient connector.

[0010] One aspect of this disclosure relates to an apparatus for performing both sterilization and flushing of an intravenous patient connector in a single device connection. The apparatus includes a guide housing having an internal first circumferential wall surface. The guide housing has a proximal end wall defining a first through-hole therein and a distal end wall defining a second through-hole. The housing has a first internal cavity defined within the first circumferential wall surface and the respective proximal and distal end walls. The apparatus also includes an end cap confined within the first internal cavity and capable of translation within the first internal cavity. The proximal end of the end cap defines an inlet and a first Luer connector adapted to engage with a corresponding Luer tip of a flushing syringe through the first through-hole of the housing. The distal end of the end cap defines a shaft having a spiked tip. The shaft defines an outlet and an internal lumen in fluid communication with the inlet and outlet of the end cap. The apparatus also includes a sterilization cap having an internal second circumferential wall surface, a proximal end wall defining a third through-hole for receiving the end cap, and a distal open end. A second Luer connector is defined on the second inner wall surface, the second Luer connector being adapted to engage with a corresponding Luer connector of the IV patient connector. The corresponding first and second cavities are aligned with each other such that the spiked tip of the end cap can be translated within a third through-hole into the second cavity of the sterilization cap. An elastomeric sleeve is confined within the second inner cavity. The sleeve has a proximal surface and a distal surface, the proximal surface being pierced by the spiked tip when the end cap is translated through the third through-hole, and the distal surface facing the open distal end of the sterilization cap. A sterilization pad is confined within the second inner cavity, between the elastomeric sleeve and the distal open end of the sterilization cap. The sterilization pad defines a fourth orifice for exposing the distal surface of the elastomeric sleeve to the distal open end of the sterilization cap. The sterilization pad also defines a distal end surface adapted to sterilize the corresponding patient IV connector when the sterilization cap is coupled to the connector. In some embodiments, a pre-filled flushing syringe is coupled to the first Luer connector of the end cap. During device operation, the connected flushing syringe moves forward into the housing, causing the spiked end of the end cap to translate into the sterilization cap. This pierces the elastomeric sleeve and allows the flushing solution contained in the connected syringe to flow directly between the inlet of the end cap and the distal open end of the sterilization cap, and subsequently into the connected patient connector.

[0011] Another aspect of this disclosure relates to a system for sterilizing and flushing an intravenous patient connector in a single device connection only. The system includes a guide housing having an internal first circumferential wall surface, a proximal end wall defining a first through-hole therein, a distal end wall defining a second through-hole therein, and a first internal cavity defined within the first circumferential wall surface and the respective proximal and distal end walls. An end cap is confined within and translatable within the first internal cavity of the housing. The proximal end of the end cap defines an inlet and a first Luer connector. The corresponding distal end of the end cap defines a shaft having a spiked tip. The shaft defines an outlet and an internal lumen in fluid communication with the inlet and outlet of the end cap. The system also includes a sterilizing cap having an internal second circumferential wall surface, a proximal end wall defining a third through-hole for receiving the shaft of the end cap, and a distal open end. The second circumferential wall surface defines a second Luer connector. The respective first and second cavities are aligned with each other such that the spiked tip of the end cap can be translated into the second cavity within the third through-hole. An elastomeric sleeve is confined within a second internal cavity. The sleeve has a proximal surface and a distal surface, the proximal surface of which is pierced by a spiked tip when the end cap is axially translated through a third through-hole, and the distal surface faces the open distal end of the sterilizing cap. A sterilizing pad is confined within the second internal cavity of the sterilizing cap, between the elastomeric sleeve and the distal open end of the sterilizing cap. The pad defines a fourth orifice for exposing the distal surface of the elastomeric sleeve to the distal open end of the sterilizing cap. The sterilizing pad defines the distal end surface. The system includes a pre-filled flushing syringe having a syringe barrel containing a flushing solution, a plunger translatable within the syringe barrel, and a third Luer connector inserted through a first through-hole of a guide housing and coupled to a first Luer connector of the end cap. The inlet of the end cap is in fluid communication with the flushing solution contained within the syringe barrel. The system also includes a patient connector having a connector body defining a fourth Luer connector, which engages with a second Luer connector within a sterilization cap, wherein the distal end surface of the sterilization pad contacts the fourth Luer connector. Advancing the flushing syringe into the first chamber causes the spiked end of the end cap to translate, piercing the elastomeric sleeve and enabling fluid communication and allowing flushing solution to flow from the flushing syringe through the end cap's inlet, internal lumen, and outlet through the patient connector. Advancing of the syringe plunger dispenses the flushing solution into the patient connector.

[0012] In some embodiments, after rinsing the patient connector with a rinsing syringe attached to the housing, both the syringe and the housing portion of the device are selectively disengaged from the sterilization cap portion of the device by releasing a selectively engaging locking mechanism. When the housing is released from the sterilization cap, the sterilization cap remains in place to seal the patient connector, preventing the connector end surface and its lumen from being exposed to the environment. In other embodiments, the entire device cap and housing, as well as the rinsing syringe attached to the housing, are selectively disengaged from the patient connector for further patient medication administration, etc. In some device embodiments, the locking mechanism facilitates the selective removal of the entire device and the attached rinsing syringe from the patient port, or only the housing and syringe, leaving the sterilization cap attached to the patient connector. In other device embodiments, the locking mechanism only allows the removal of the housing and syringe. In still other device embodiments, the sterilization cap and housing are permanently coupled to each other; the entire device and the rinsing syringe are removed by disengaging the sterilization cap from the IV patient connector. Attached Figure Description

[0013] Exemplary embodiments of the present disclosure are further described in the following detailed description in conjunction with the accompanying drawings, in which:

[0014] Figure 1 This is an isometric view of an embodiment of the disinfection and rinsing apparatus of this disclosure before the removal of the sheet peel-off cap seal and the connection of the disinfection cap portion of the apparatus to the exemplary IV connector of a medical patient;

[0015] Figure 2 yes Figure 1 Isometric view of the distal end of the device;

[0016] Figure 3 yes Figure 1 An exploded view of the device;

[0017] Figure 4 yes Figure 1 An axial cross-sectional view of the device after its sterilization cap portion is attached to the exemplary IV connector, before the flushing syringe is moved forward to engage with the IV connector;

[0018] Figure 5 yes Figure 4 A cross-sectional view of the device after its sterilization cap portion is attached to the exemplary IV connector and after the rinsing syringe is moved forward to engage with the IV connector;

[0019] Figure 6 yes Figure 1 A detailed front view of a portion of the twist-lock locking engagement mechanism of an embodiment of the device, which selectively engages the sterilization cap to the housing of the device;

[0020] Figure 7 yes Figures 1 to 6 An isometric view of the device after the housing portion of the device and its attached flushing syringe have been selectively separated from the sterilization cap portion of the device.

[0021] Figure 8 It maintains connection to the IV patient connector after selective separation of the device housing. Figure 7 The axial cross-section of the sterilization cap portion of the device;

[0022] Figure 9 This is a second embodiment of the disinfection and rinsing device of the present disclosure after its disinfection cap portion is attached to an exemplary IV connector of a medical patient and before the rinsing syringe is moved forward to engage with the IV connector;

[0023] Figure 10 yes Figure 9 An enlarged isometric view of a portion of the twist-lock locking engagement mechanism of an embodiment of the device, which selectively engages the sterilization cap to the housing of the device;

[0024] Figure 11 yes Figure 9 and Figure 10 An isometric view of the entire device and its attached flushing syringe after selective separation from the IV patient connector.

[0025] Figure 12 yes Figure 9 and Figure 10 An isometric view of the device after the housing portion of the device and its attached flushing syringe have been selectively separated from the sterilization cap portion of the device, wherein the cap remains connected to the patient connector.

[0026] Figure 13 This is an isometric view of a third embodiment of the disinfection and rinsing apparatus of this disclosure after its disinfection cap portion is coupled to an exemplary IV connector of a medical patient and after the rinsing syringe is moved forward to engage with the IV connector.

[0027] Figure 14 yes Figure 13 A detailed isometric view of a portion of the twist lock locking engagement mechanism in an embodiment of the device;

[0028] Figure 15 yes Figure 13 and Figure 14 The device, after its housing portion and attached flushing syringe are separated from the device's sterilization cap portion, allows its sterilization cap portion to remain connected to the IV patient connector in an isometric view.

[0029] Figure 16 This is an isometric view of a fourth embodiment of the disinfection and rinsing apparatus and the attached rinsing syringe disclosed herein;

[0030] Figure 17 is Figure 16 an exploded view of the device;

[0031] Figure 18 is Figure 16 an axial cross-sectional view of the device after its disinfection cap portion is coupled to an exemplary IV connector and before the flush syringe is advanced to engage the IV connector;

[0032] Figure 19 is Figure 16 an axial cross-sectional view of the device after its disinfection cap portion is coupled to an exemplary IV connector and after the flush syringe is advanced to engage the IV connector;

[0033] Figure 20 is Figure 16 an isometric view of the device after it is completely separated from the IV patient connector.

[0034] For ease of understanding, the same reference numerals are used, where possible, to designate the same elements common to the figures. The figures are not drawn to scale. Detailed Description

[0035] The patient connector disinfection and flush device of the present disclosure only requires a single coupling of the device's disinfection cap to the IV patient connector to scrub the patient connector and administer a flush solution through the connector via a flush syringe that has been coupled to the housing portion of the device. During an initial patient connector scrubbing and flushing operation, the disinfection cap and the housing portion of the device are coupled together. Thereafter, in some embodiments, the housing and its attached used flush syringe may be selectively separated from the device's disinfection cap portion such that the disinfection cap remains in place on the patient connector. In other embodiments, the entire device, including the disinfection cap, housing, and separately coupled flush syringe, is disengaged from the patient connector such that a medicament can be administered through the connector. Optionally, after medicament administration, a second device of the present disclosure is used to provide a final scrubbing and flushing of the patient connector; thus, after its guide housing and used flush syringe are separated, its disinfection cap remains in place on the patient connector.

[0036] In the present disclosure, the following convention is followed, where the distal end of the device is the end that is closest to the patient (e.g., for delivering one or more medicaments to the patient), and the proximal end of the device is the end that is remote from the patient and closest to the clinician or other healthcare practitioner. Regarding the terms used in the present disclosure, the following definitions are provided.

[0037] As used herein, the use of "a", "an", and "the" includes both singular and plural.

[0038] As used in this article, the term “catheter-related bloodstream infection” or “CRBSI” refers to any infection caused by the presence of a patient’s connector, catheter, or IV line.

[0039] As used herein, the term "Luer connector" refers to a connecting collar for medical devices (e.g., VADs), representing a standard method of attaching needleless patient connectors, syringes, catheters, hubed needles, IV tubing, etc. A Luer connector consists of male and female interlocking tubes that are slightly tapered to better hold them together, even with simple pressure / torsion mating. Threaded Luer connectors may include additional threaded outer edges for added strength and security. The male end of the Luer connector is generally associated with a flushing syringe and may interlock with and connect to the female end located on a patient connector (including, but not limited to, needleless patient connectors) or other type of vascular access device (VAD). A Luer connector includes a distal end, a proximal end, an irregularly shaped outer wall, and a molded central passage for fluid communication from the syringe barrel chamber to the hub of the patient connector or other type of vascular access device (VAD). The Luer connector also has a distal end channel and a proximal end channel, the distal end channel for releasably attaching the Luer connector to the hub of the VAD, and the proximal end channel for releasably attaching the Luer connector to the barrel of the syringe.

[0040] 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.

[0041] As will readily be appreciated by those skilled in the art, while 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 individually or to require a specific spatial orientation to implement various aspects of the embodiments of this disclosure.

[0042] According to a further exemplary embodiment of the embodiments of this disclosure, a needleless connector type patient connector or other medical device to be cleaned may include: a female thread, the size and thread pattern of which are configured to engage with a standard ISO 594-2 type male fitting; and / or a male thread, the size and thread pattern of which are configured 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.

[0043] In one or more embodiments, the patient connector of the female connector type or other medical device to be cleaned 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.

[0044] Before describing exemplary embodiments of this disclosure, it should be understood that this disclosure is not limited to the details of the construction or process steps set forth in the following description. The patient connector disinfection and rinsing concept of this disclosure can be implemented in other embodiments and can be practiced or carried out in a variety of ways.

[0045] The following non-limiting examples illustrate the principles of one or more embodiments according to this disclosure. Figures 1 to 20 In this embodiment, the exemplary patient connector 30 is a valve-type needleless connector (NFC). The proximal end of the patient connector 30 incorporates a threaded Luer connector 32, which defines a proximal axial face 34 and an internal passage 36 for communication with a downstream IV line or other VAD (not shown) coupled to the distal end 38 of the connector. The threaded Luer connector 32 is disinfected and flushed using one or more embodiments of the disinfection and flushing apparatus disclosed herein. After cleaning and flushing the patient connector 30, a healthcare provider may subsequently administer one or more medications to the patient, typically disinfecting the connector before and after each new syringe is coupled to it. After administering the last medication to the patient, the healthcare provider typically disinfects and flushes the patient connector 30 again before attaching a cap to its threaded Luer connector 32.

[0046] Now refer to the attached diagram. Figures 1 to 8 The first aspect or embodiment of this disclosure is a system 40 for disinfecting and rinsing an intravenous patient connector 30. For example... Figures 1 to 3 As shown, system 40 includes a device 42 for sterilizing and flushing an intravenous patient connector. Externally visible components of device 42 include a guide housing 44 and a sterilization cap 46. System 40 also includes a flushing syringe 48 coupled to the guide housing 44 of device 42. The flushing syringe 48 includes a syringe barrel 47 containing a flushing solution and a translational plunger 49. In some embodiments, the sterile device 42 is individually packaged for coupling with a separate sterile flushing syringe 48 (pre-filled or field-filled) prior to patient administration. In other embodiments, the sterile device 42 and the pre-filled flushing syringe 48 are coupled during manufacturing and shipped in sterile packaging for patient administration by a healthcare provider.

[0047] Figures 2 to 5 The internal components of device 42 are illustrated. A guide housing 44 has an internal first circumferential wall surface 50, a proximal end wall 52 defining a first through-hole 54 therein, a distal end wall 56 defining a second through-hole 58 therein, and a first internal cavity 60 defined within the first circumferential wall surface and the respective proximal and distal end walls. An end cap 62 is confined within the first internal cavity 60 of the guide housing 44 and is translatable within the first internal cavity 60. The proximal end 64 of the end cap 62 defines an inlet 66 and a first Luer connector 68 for coupling to a corresponding Luer tip 70 and threaded Luer connector 72 of the syringe 48. The first Luer connector 68 effectively allows the end cap 62 to replace known needleless guides typically used with known flushing syringes. Therefore, the end cap 62 of device 42 is compatible with known flushing syringe designs. The distal end of the end cap 62 defines a shaft 74 with a spiked tip 76. The shaft 74 is hollow, defining a lumen 78 in fluid communication with the inlet 66 and outlet 80 of the end cap 62. A threaded connection between the first Luer connector 68 and the corresponding threaded Luer connector 72 interconnects the syringe 48 and the guide housing 44. This establishes a fluid path for discharging the saline flushing solution contained within the syringe barrel 47 through the Luer end 70 of the end cap 62, the inlet 66, the internal lumen 78, and the outlet 80, respectively, then through the sterilization cap 46 and into the patient connector 30.

[0048] In summary, the guide housing 44 serves as a shell to confine the end cap 62 therein, to guide the translation of the end cap within the first internal cavity 60, and to prevent accidental puncture of the elastomeric sleeve 94 by the barbed tip 76 before intended flushing of the patient connector 30. The structure of the guide housing 44 enables it to be coupled to the sterilization cap 46.

[0049] The sterilization cap 46 has an internal second circumferential wall surface 82. The annular proximal end wall 84 of the sterilization cap 46 defines a third through-hole 86 for receiving the shaft 74 of the end cap 62. The sterilization cap 46 has a distal open end 88 for receiving the patient connector 30; its second circumferential wall surface 82 defines a second Luer connector 90 for engagement with a corresponding threaded Luer connector 32 of the patient connector. A second internal cavity 92 is defined within the second circumferential wall surface 82, the proximal end wall 84, and the distal open end 88 of the sterilization cap 46.

[0050] The sterilization cap 46 and the guide housing 44 are slidably connected to each other in a nested manner; when nested, the corresponding first cavity 60 and second cavity 92 are aligned with each other, such that the spiked end 76 of the end cap 62 can be translated into the second cavity within the third through hole 86. Although Figure 4 and Figure 5 The embodiment shows a sterilization cap 46 nested within a guide housing 44, but in other embodiments, the nesting orientation is reversed: the guide housing is nested within the sterilization cap. While this embodiment also shows axial symmetry between the guide housing 44 and the sterilization cap 46, with concentric end caps 62 aligned, in other embodiments they are axially asymmetrical.

[0051] An elastomeric sleeve 94 is confined within a second internal cavity 92 of a sterilizing cap 46, serving as a punctureable, resealable diaphragm for the cap. The elastomeric sleeve 94 has a peripheral flange 96 confined between the proximal end wall 84 of the sterilizing cap 46 and an annular inner bushing 98. The elastomeric sleeve 94 has a tubular rod portion 100 projecting into the distal portion of the second internal cavity 92, the tubular rod portion 100 for receiving the shaft 74 and the spiked end 76 of the end cap 62. The corresponding distal end 102 of the tubular rod portion 100 can be punctured by the spiked end 76. The tubular rod portion 100 of the elastomeric sleeve 94 includes an axially expandable bellows 104 that extends axially when the shaft 74 of the end cap 62 is inserted therein. Figure 4 and Figure 5 When the axis 74 of the end cap 62 translates through the third through hole 86 and the inner bushing 98 of the sterilization cap 46, the proximal surface 106 of the elastomer sleeve 94 is pierced by the spiked end 76, as indicated by arrow A. The distal surface 108 of the elastomer sleeve 94 faces the distal open end 88 of the sterilization cap 46.

[0052] During the assembly of the sterilization cap 46, the elastomeric sleeve 94 is inserted into the second inner cavity 92 from the proximal end 64 of the cap, and the tubular rod portion 100 passes through the central opening of the inner bushing 98. Next, the annular proximal end wall 84 is inserted into the second inner cavity, confining the peripheral flange 96 of the sleeve.

[0053] The components of the disinfection and rinsing device 42, as well as some other embodiments described herein, are constructed by injection molding or vacuum thermoforming. Exemplary materials used to construct the guide housing 44, disinfection cap 46, and end cap 62 include thermoplastic polymers. The elastomeric sleeve 94 is constructed by compression molding of cross-linked rubber or thermoplastic elastomer material. Exemplary hardness ranges for the elastomeric sleeve are 25-100 Shore A, more particularly 45-80 Shore A. Generally, components of the disinfection and rinsing device 42 are constructed from medical-grade plastic materials such as polycarbonate, polypropylene, polyethylene, ethylene glycol-modified polyethylene terephthalate, acrylonitrile-butadiene-styrene, or any other moldable plastic material used in medical devices.

[0054] like Figure 2 , Figure 4 , Figure 5 and Figure 8 As illustrated, a disinfection pad 110 is confined within a second internal cavity 92, between the elastomeric sleeve 94 and the distal open end 88 of the disinfection cap 46. The disinfection pad 110 defines a fourth aperture 112 for exposing the distal surface 108 of the elastomeric sleeve 94 to the distal open end 88 of the disinfection cap 46. The disinfection pad 110 defines a distal end surface 114 that contacts at least the distal end surface 38 of the patient connector 30 when the disinfection cap is attached or otherwise coupled to the patient connector. In some embodiments, the disinfection pad 110 is compressed when the disinfection cap 46 is attached to the patient connector 30. In some embodiments, the disinfection pad 110 further includes an antimicrobial material and / or is impregnated with an antimicrobial agent. More specifically, in some embodiments, the disinfection pad 110 is a disinfection sponge or other alternative absorbent material retained within the disinfection cap 46. In some embodiments, the disinfection pad 110 includes an absorbent or permeable liquid or gel disinfectant or antimicrobial agent for disinfecting the patient connector 30 or other medical devices to be cleaned with the disinfection cap 46. In one or more embodiments, the absorbent material comprising the disinfection pad 110 is a nonwoven material, foam, or sponge with a porous structure. In one specific embodiment, the foam is polyurethane foam. In another specific embodiment, the absorbent material is a sponge.

[0055] The disinfection pad 110 retains the disinfectant or antimicrobial agent in its porous structure due to surface tension and releases the disinfectant or antimicrobial agent when squeezed or compressed upon contact with the patient connector 30 or other medical device to be cleaned by the disinfection cap 46. The disinfection cap 46 is compatible with a variety of disinfectants. In one or more embodiments, the disinfectant or antimicrobial agent includes variants of alcohol or chlorohexidine. In one or more embodiments, the disinfectant or antimicrobial agent is selected from the group consisting essentially of: isopropanol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, tert-butylhydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone-iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexadiidine, triclosan, hydrogen peroxide, colloidal silver, benzyl chloride, benzalkonium chloride, otetanidin, antibiotics, and mixtures thereof. In one specific embodiment, the disinfectant or antimicrobial agent includes at least one of chlorhexidine gluconate and chlorhexidine acetate. In one or more embodiments, the disinfectant or antimicrobial agent is a fluid or gel. In one or more specific embodiments, the disinfectant or antimicrobial agent is 70% isopropanol (IPA). Figure 4 and Figure 5 As shown, the elastomeric sleeve 94 serves as a seal to prevent leakage of disinfectant or antimicrobial agents (e.g., IPA) into the patient connector 30 before and during the interconnection of the patient connector and the sterilization cap 46. The self-sealing distal end 102 of the elastomeric sleeve 94 also seals the sterilization cap 46 after the syringe is withdrawn, which prevents IPA leakage and exposure of the patient connector 30 to a non-sterile external environment.

[0056] When the sterile cap 46 is attached to the patient connector 30, the cap rotation required to mate the threaded engagement between the corresponding threaded Luer connectors 32 and 90 ensures thorough cleaning of the connector, conforming to the Infusion Nurse Standard (INS) guidelines. The threaded engagement process also establishes a leak-proof connection between the sterile cap 46 and the patient connector 30.

[0057] A peel-off cap 116 covers the distal open end 88 of the sterilization cap 46. In other embodiments, the device does not include a peel-off cap covering the distal open end of the sterilization cap. In one or more embodiments, the peel-off cap 116 is a peelable seal comprising a peel-off top of an aluminum or multilayer polymer film. The peel-off cap 116 minimizes the entry of potential particulate hazards and also provides a substantially impermeable shell to the distal open end 88 of the sterilization cap 46, providing leak-proof protection for a second internal cavity 92 formed within the sterilization cap, protecting the absorbed or permeated contents of the sterilization pad 110 or other sterilizing media contained within the second internal cavity, and / or maintaining a sealed sterile environment within the sterilization cap. The sealing composition of the peel-off cap 116 provides a sufficient environmental seal between its aluminum or polymer film and the distal open end 88 of the sterilization cap within a range of temperature, pressure, and humidity levels expected within a medical treatment facility. In some embodiments, the peel-off cap 116 is heat-sealed or inductively sealed to the distal open end 88 of the sterilization cap 46. In other embodiments, the sheet release cap 116 is sealed to the distal open end 88 of the sterilization cap 46 with pressure or heat-sensitive adhesive.

[0058] The guide housing 44 has a pivotable guide housing cover 118 to prevent accidental forward translation of the syringe 48 and end cap 62 within the first internal cavity 60 of the guide housing. The distal end 120 of the guide housing cover 118 is pivotally coupled to the guide housing 44. Figure 4 As depicted, the proximal end 122 of the guide housing cover 118 protrudes axially away from the proximal end wall 52 of the housing in a first position oriented opposite to the syringe 48. When the guide housing cover 118 is in its first position, it prevents forward movement of the syringe 48 and the interconnected end cap 62; this prevents the connecting barbed tip 76 of the end cap 62 from piercing the distal end 102 of the tubular rod portion 100 of the elastomeric sleeve 94. The guide housing cover 118 pivots to [the desired position] before healthcare personnel flush the patient connector 30. Figure 5 The syringe 48 is positioned laterally away from the guide housing 44 in the second position, where it no longer obstructs the forward movement of the syringe 48 within the first internal cavity 60 of the guide housing 44. As the syringe 48 moves forward, the spiked end 76 of the end cap 62 pierces the distal end 102 of the elastomeric sleeve 94.

[0059] As previously described, the sterilization cap 46 and the guide housing 44 are slidably connected to each other in a nested manner. In some embodiments, the slidably connected guide housing and sterilization cap are connected together by a locking mechanism. Figures 1 to 8 In device embodiment 42, the locking mechanism facilitates selectively securing the sterilization cap 46 to the patient connector 30 while removing the guide housing 44 and the used syringe 48.

[0060] Figures 1 to 8 The locking mechanism is a twist-lock, bayonet-type locking mechanism, comprising two pairs of interlocking, radially outward-protruding bayonet pins 124 and a female receiver slot 126, circumferentially spaced apart in a 180-degree opposing orientation. (Reference) Figure 6 Each female receiver slot 126 has an L-shaped profile, including an axially aligned first slot segment 128 and a laterally aligned second slot segment 130. In one or more alternative embodiments, each female receiver slot 126 has a T-shaped or J-shaped profile. The lateral end of the second slot segment 130 terminates in a first necked serif 132 and a second necked serif 134 that hold a corresponding bayonet pin 124. The bayonet pin 124 engages within the first serif 132 when the second Luer connector 90 of the sterilization cap 46 portion of the assembled sterilization and rinsing system 40 is threadedly engaged on the corresponding threaded Luer connector 32 of the patient connector 30. Conversely, the bayonet pin 124 engages within the second serif 134 when the entire connected guide housing 44, sterilization cap 46, and rinsing syringe 48 are to be removed from the patient connector 30.

[0061] like Figure 7 and Figure 8 As shown, when the guide housing 44 and the sterilization cap 46 are rotated relative to each other such that the bayonet pin 124 is aligned with the axially aligned first slot segment 128, the housing and cap can be axially separated from each other, allowing the guide housing and the flushing syringe 48 to be separated and withdrawn from the patient connector 30, while the sterilization cap is engaged with the patient connector. During separation and withdrawal, the syringe 48 retracts from the guide housing 44, separating the spiked end 76 and outlet 80 of the end cap 62 from the elastomeric sleeve 94 of the sterilization cap 46, thereby isolating the sterile patient connector 30 from the non-sterile external environment. To facilitate the torsional rotation of the system 40 components relative to each other, the external gripping fins 136 are oriented on the guide housing 44, and the external gripping fins 138 are oriented on the sterilization cap 46.

[0062] In some embodiments, a single mating engagement pin 124 and a female receiver slot 126 are incorporated into a locking mechanism. In other device embodiments, the locking mechanism includes more than two pairs of mating pins and receiver slots. In some embodiments, the pins are oriented on the guide housing, while the receiver slots are oriented in the sterilization cap.

[0063] Figures 9 to 12 A disinfection and rinsing device 142 with a second twist-lock bayonet locking mechanism embodiment is depicted, which facilitates the selective securing of a disinfection cap 46 to a patient connector 30. The remaining structural components of the system and their operation correspond to... Figures 1 to 8The second embodiment of the twist-lock mechanism includes a latch pin 124 on the sterilization cap 46 and a T-shaped receiver slot 140 formed in the guide housing 144. The T-shaped receiver slot 140 includes an axially aligned third slot segment 143 and a laterally aligned fourth slot segment 145. The lateral end of the fourth slot segment 145 terminates at a third neck stop 146 and a fourth neck stop 148 that hold the corresponding latch pin 124. When the second Luer connector 90 of the sterilization cap 46 portion of the assembled sterilization and rinsing system is threadedly engaged and tightened onto the corresponding threaded Luer connector 32 of the patient connector 30, the latch pin 124 engages within the third stop 146 (see [link to documentation]). Figure 9 and Figure 10 (arrow T). Conversely, when the entire connecting guide housing 144, sterilization cap 46, and flushing syringe 48 are to be removed from the patient connector 30, the bayonet 124 engages within the fourth stop portion 148 (see arrow T). Figure 11 Arrow L). Figure 12 As shown, when the guide housing 144 and the sterilization cap 46 are rotated relative to each other such that the bayonet pin 124 is aligned with the axially aligned fourth slot segment 145, the housing and cap can be axially separated from each other, thereby allowing the guide housing and the flushing syringe 48 to be separated and withdrawn from the patient connector 30, while the sterilization cap remains attached to the patient connector.

[0064] Figures 13 to 15 A disinfection and rinsing device 242 with a third twist-lock bayonet locking mechanism embodiment is depicted, which always secures the disinfection cap 46 to the patient connector 30 after the guide housing 244 and the used syringe 48 have been separated. The remaining structural components of the system and their operation correspond to... Figures 1 to 8 The third embodiment of the twist-lock mechanism includes a locking pin 124 on the sterilization cap 46 and a J-shaped receiver slot 150 formed in the guide housing 244. The J-shaped receiver slot 150 includes an axially aligned fifth slot segment 152 and a curved sixth slot segment 154. The lateral end of the sixth slot segment 154 terminates at a fifth neck stop 156, which holds the corresponding locking pin 124. When the second Luer connector 90 of the sterilization cap 46 portion of the assembled sterilization and rinsing system 240 is threadedly engaged and tightened onto the corresponding threaded Luer connector 32 of the patient connector 30, the locking pin 124 engages within the fifth stop 156 (see [link to previous embodiment]). Figure 13 Arrow T). Conversely, when the guide housing 244 is loose relative to the sterilization cap 46 (see arrow T). Figure 14Arrow L), the bayonet pin 124 travels only along the curved sixth slot section 154 and aligns with the axially aligned fifth slot section 152. Then, the relative retraction of the guide housing 244 separates it from the sterilization cap 46, as Figure 15 As shown in the image.

[0065] Figures 16 to 20 The disinfection and rinsing device 342 of the system 340 shown is designed solely for complete disengagement from the patient connector 30 after the IV rinsing procedure is completed. Device 342 is adapted to disinfect and rinse the patient connector 30, through which medication is then administered. After medication administration, the healthcare provider may optionally disinfect and rinse the patient connector 30 using one of the previously described devices 42, 142, or 242, and thereafter leave the disinfection cap 46 in place on the patient connector.

[0066] Device 342 permanently connects the guide housing 344 and the sterilization cap 346 to each other. After the rinsing procedure is completed, the sterilization cap 346 is unscrewed from the patient connector 30, as follows. Figure 20 As shown in the diagram. The internal components of device 342 are generally similar to... Figures 1 to 15 The internal components of device embodiments 42, 142, and 242 have the same function. They have the same... Figures 1 to 15 In the embodiments, components in device 342 with substantially the same structure as corresponding parts share the same reference numerals in the drawings. For the sake of brevity, descriptions of the structure and operation of substantially the same parts are not repeated. Figures 16 to 20 Among them, those components with different structures include a single-structure guide housing 344 / sterilization cap 346 and an elastomer sleeve 394. (See reference) Figure 18 and Figure 19 The elastomer sleeve 394 includes a sleeve flange 396, a non-axially extended tubular shaft portion 300, and a distal end 302 pierced by the spiked end 76 of the end cap 62. To flush the patient connector 30, the guide housing cover 118 pivots to its second position, allowing the end cap 62 and the coupled syringe 48 to advance within the first internal cavity 60 and pierce the distal end 302 of the elastomer sleeve 394 (see [link to documentation]). Figure 19 The tip 76 of the end cap 62 pierces the distal end 302 of the elastomeric sleeve 394, establishing a fluid communication path from the syringe 48 through the outlet 80 of the end cap and subsequently into the internal passage 36 of the patient connector 30. Figure 20 As shown, after the patient connector 30 flushing process is completed, the entire device 342 is unscrewed from the patient connector.

[0067] During assembly of device 342, the tubular shaft portion 300 of the elastomer sleeve 394 is inserted through the inner bushing 98 formed within the guide housing 344 / sterilization cap 346, followed by the insertion of the end cap 62. Subsequently, the annular proximal end wall 52 is inserted into the first internal cavity 60 to hold and confine the end cap 62 within the internal cavity. The threaded Luer connector 72 of the syringe 48 is engaged with the corresponding first Luer connector 68 of the end cap 62, and device 342 is ready to be coupled to the patient connector 30 for sterilization and rinsing, as... Figure 18 As shown in the image.

[0068] An exemplary procedure for using any of the apparatus embodiments 42 or 142 of this disclosure in performing a saline-drug administration-saline (SAS) or saline-drug administration-saline-heparin (SASH) workflow is as follows:

[0069] 1. Remove device 42 or 142 from its sterile packaging unit and attach a pre-filled flushing syringe 48 (e.g., containing saline or heparin flushing solution) to the end cap 62 in the guide housing 44, if it has not yet been attached to the packaging unit as a complete system device 40.

[0070] 2. Remove the sheet peeling cap 116 from the sterilization cap 46.

[0071] 3. Connect the sterilization cap 46 to the patient connector 30; the threaded connections of these components are cleaned by wiping the patient connector with a sterilization pad 110; this ensures thorough sterilization of the connector (see [link to sterilization instructions]). Figure 4 ).

[0072] 4. Raise the guide housing cover 118 to its second position and advance the plunger 49 of the syringe 48 to advance the plunger and end cap 62 within the guide housing 44 (see...). Figure 5 ).

[0073] 5. Initially, the plunger 49 is pushed forward to advance the entire syringe 48 and the distal end 76 of the end cap to pierce the distal end 102 of the elastomeric sleeve 94. Once the distal end 102 is pierced, a fluid path is opened between the pre-filled syringe 48 and the patient connector 30 (see [link to original text]). Figure 5 ).

[0074] 6. Continue to advance plunger 49 to flush patient connector 30 and its downstream VAD.

[0075] 7. After completing the patient connector 30 flushing, there are two options:

[0076] a. Keep the patient connector 30 stationary while simultaneously twisting the sterilization cap 46 counterclockwise, as shown. Figure 11As indicated by arrow L, before administering medication to the patient via the patient connector, as part of an intermittent flushing procedure, the entire device 142 may be unscrewed and disassembled from the patient connector, and / or the saline-administration-saline or saline-administration-saline-heparin workflow may continue (this is also possible for devices 242 or 342); or

[0077] b. As part of the final flushing procedure of SAS or SASH, while keeping the sterile cap 46 stationary, twist and pull the guide housing 44 to disengage each of the bayonet pins 124 of the corresponding locking mechanism from its corresponding female receiver slot 126, separating the guide housing and syringe 48 from the sterile cap, so that the cap is engaged with the patient connector (also using device 142 or 242).

[0078] Example

[0079] Example (a): A device 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-hole therein, a distal end wall defining a second through-hole therein, and a first internal cavity defined within the first circumferential wall surface and the corresponding proximal and distal end walls; an end cap confined within the first internal cavity and translatable within the first internal cavity, the proximal end of the end cap defining an inlet and a first Luer connector adapted to engage a corresponding Luer tip of a flushing syringe through the first through-hole, the distal end of the end cap defining an axis having a spiked tip, the axis defining an outlet and an internal lumen in fluid communication with the inlet and outlet of the end cap; a disinfection cap having an internal second circumferential wall surface, a proximal end wall defining a third through-hole for receiving the axis of the end cap, and a distal open end, the second circumferential wall surface defining a second Luer connector, the second Luer connector... The device is adapted to engage with a corresponding Luer connector for a patient connector; the first and second internal cavities are aligned with each other such that the spiked end of the end cap can translate into the second cavity within the third through-hole; an elastomeric sleeve confined within the second internal cavity, the sleeve having a proximal surface and a distal surface, the proximal surface being pierced by the spiked end as the end cap axially translates through the third through-hole, the distal surface facing the open distal end of the sterilization cap; and a sterilization pad confined within the second internal cavity, between the elastomeric sleeve and the distal open end of the sterilization cap, the pad defining a fourth orifice for exposing the distal surface of the elastomeric sleeve to the distal open end of the sterilization cap, the sterilization pad defining a distal end surface adapted to sterilize the patient connector when the sterilization cap is coupled to the connector; wherein the translation of the spiked end 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 sterilization cap.

[0080] Example (b): The device according to Example (a) further includes a selectively engaging locking mechanism that connects the distal end wall of the guide housing to the proximal end wall of the sterilization cap.

[0081] Example (c): The device according to Example (b) further includes the distal end wall of the guide housing and the proximal end wall of the sterilization cap nested together and slidably engaged, wherein selective engagement and disengagement are facilitated by engagement and disengagement of the locking mechanism.

[0082] Example (d): According to the apparatus of Example (c), the selectively engaging locking mechanism includes a torsion connector.

[0083] Example (e): According to the device described in Example (d), the torsion connector includes at least one snap pin formed on the guide housing or the sterilization cap and a corresponding receiver slot formed on the other of the guide housing or the sterilization cap.

[0084] Example (f): According to the device of Example (e), at least one receiver slot has a T-shaped profile, an L-shaped profile, or a J-shaped profile, including a snap pin 124 on the sterilization cap 46 and a J-shaped receiver slot 150 formed in the guide housing.

[0085] Example (g): In the apparatus according to Example (a), the guide housing and the sterilization cap are permanently connected to each other.

[0086] Example (h): According to the device of Example (a), the elastomeric sleeve has a peripheral flange abutting against the proximal end wall of the sterilization cap and a hollow tubular rod portion protruding into the second cavity for receiving the shaft of the end cap, the distal end of the tubular rod being pierced by the spiked end.

[0087] Example (i): The apparatus according to Example (h) further includes the tubular rod having an expandable bellows configured to expand axially when the shaft of the end cap is inserted therein.

[0088] Example (j): The device according to Example (a) wherein the guide housing has a cover, the distal end of the cover being coupled to the housing, and the proximal end of the cover protruding axially away from the proximal end of the housing in a first position and displaced away from the proximal end of the housing in a second position, thereby preventing the end cap from moving forward within the first internal cavity of the guide housing when the cover is in its first position, but allowing the forward movement when the cover is in its second position, the forward movement enabling the spiked end of the end cap to pierce the elastomeric sleeve.

[0089] Example (k): The apparatus according to Example (a) further includes a sheet peeling cap covering the distal open end of the sterilization cap.

[0090] Example (l): According to the device described in Example (a), the disinfection pad further includes an antimicrobial material.

[0091] Example (m): The device according to Example (l) wherein the disinfection pad is compressible when the disinfection cap is attached to the patient connector.

[0092] Example (n): According to the apparatus of Example (a), the first Luer connector and / or the second Luer connector include threaded Luer connectors.

[0093] Example (o): 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-hole therein, a distal end wall defining a second through-hole therein, and a first internal cavity defined within the first circumferential wall surface and the corresponding proximal and distal end walls; an end cap confined within the first internal cavity and translatable within the first internal cavity, the proximal end of the end cap defining an inlet and a first Luer connector, the distal end of the end cap defining an axis having a spiked tip, the axis defining an outlet and an outlet connected to the inlet and... An internal cavity with fluid communication to the outlet; a sterilization cap having an internal second circumferential wall surface, a proximal end wall defining a third through-hole for receiving the end cap's axis, 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 other such that the spiked end of the end cap can translate into the second cavity within the third through-hole; an elastomeric sleeve confined within the second internal cavity, the sleeve having a proximal surface and a distal surface, the proximal surface being pierced by the spiked end when the end cap's axis translates through the third through-hole, the distal surface facing the open distal end of the sterilization cap. The device includes: a pre-filled flushing syringe having a syringe barrel containing a flushing solution, a plunger capable of translation within the syringe barrel, and a third Luer connector inserted through a first through-hole in the guide housing and coupled to a first Luer connector of the end cap, the inlet of the end cap being received within the syringe barrel. The flushing solution is in fluid communication; and a patient connector includes a connector body defining a fourth Luer connector coupled to a second Luer connector within the sterilization cap, wherein the distal end surface of the sterilization pad contacts the fourth Luer connector; wherein advancing the flushing syringe into the first cavity causes the spiked end of the end cap to translate, piercing the elastomeric sleeve and enabling the flushing solution to be in fluid communication between the flushing syringe and the patient connector via the inlet, internal lumen, and outlet of the end cap, and wherein forward movement of the translational plunger dispenses the flushing solution into the patient connector.

[0094] Example (p): The system according to Example (o) further includes a selectively engaging locking mechanism that connects the distal end wall of the guide housing to the proximal end wall of the sterilization cap for selectively separating the guide housing and the flushing syringe from the sterilization cap.

[0095] Example (q): In the system according to Example (p), the selectively engaging locking mechanism includes a torsion connector.

[0096] Example (r): According to the system described in Example (q), the torsion connector includes at least one snap pin formed on the guide housing or the sterilization cap and a corresponding receiver slot formed on the other of the guide housing or the sterilization cap.

[0097] Example(s): According to the system of Example(r), at least one receiver slot has a T-shaped or L-shaped profile for facilitating selective separation of the guide housing and the flushing syringe from the disinfection cap when the guide housing is twisted relative to the disinfection cap in a first direction, and for removing the disinfection cap together with the guide housing and the flushing syringe from the patient connector when the guide housing is twisted relative to the disinfection cap in a second direction.

[0098] Example (t): According to the system of Example (r), at least one receiver slot has a J-shaped profile for selectively separating the guide housing and the flushing syringe from the disinfection cap when the guide housing is twisted relative to the disinfection cap in a first direction, such that the disinfection cap remains connected to the patient connector.

[0099] Example (u): According to the system described in Example (o), the guide housing and the sterilization cap are permanently coupled to each other, such that detachment of the sterilization cap from the patient connector separates the entire system from the patient connector.

[0100] Example (v): The system according to Example (o) wherein the guide housing has a cap, the distal end of the cap being coupled to the housing, and the proximal end of the cap protruding axially away from the proximal end of the housing in a first position and displaced away from the proximal end of the housing in a second position, thereby preventing the syringe and the coupled end cap from moving forward within a first internal cavity of the guide housing when the cap is in its first position, but allowing the forward movement when the cap is in its second position, such forward movement enabling the spiked tip of the end cap to pierce the elastomeric sleeve.

[0101] Example (w): The system according to Example (o) further includes a sheet peeling cap covering the distal open end of the sterilization cap.

[0102] Example (x): According to the system described in Example (o), the disinfection pad further includes an antimicrobial material.

[0103] Example (y): The system according to Example (x) further includes a compressible disinfection pad that is compressed when the disinfection cap is attached to the patient connector.

[0104] Example (z): According to the system described in Example (o), the corresponding pair of connected first Luer connectors and third Luer connectors and / or the corresponding pair of connected second Luer connectors and fourth Luer connectors include threaded Luer connectors.

[0105] In this specification, the terms "one embodiment," "some embodiments," "various embodiments," "one or more embodiments," or "an 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 one 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 one or more embodiments in any suitable manner.

[0106] Although the disclosure herein has been described with reference to specific 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. Therefore, this disclosure is intended to include modifications and variations within the scope of the appended claims and their equivalents.

Claims

1. A device for disinfecting and rinsing intravenous patient connectors, comprising: A guide housing having an inner first circumferential wall surface, a proximal end wall defining a first through-hole therein, a distal end wall defining a second through-hole therein, and a first internal cavity defined within the first circumferential wall surface and the corresponding proximal and distal end walls. An end cap, which is confined within the first internal cavity and is translatable within the first internal cavity, the proximal end of the end cap defining an inlet and a first Luer connector adapted to engage with a corresponding Luer end of a flushing syringe through the first through-hole, the distal end of the end cap defining an axis with a spiked end, the axis defining an outlet and an internal lumen in fluid communication with the inlet and outlet of the end cap; A sterilization cap having an inner second circumferential wall surface, a proximal end wall defining a third through-hole for receiving the end cap, and a distal open end, the second circumferential wall surface defining a second Luer connector adapted to engage with a corresponding Luer connector of a patient connector. The first and second internal cavities are aligned with each other, such that the spiked end of the end cap can be translated into the second cavity within the third through-hole. An elastomeric sleeve, confined within a second internal cavity, having a proximal surface and a distal surface, the proximal surface being pierced by the tip of a spike as the end cap undergoes axial translation through the third through-hole, the distal surface facing the open distal end of the sterilization cap; and A disinfection pad, which is confined within a second internal cavity, between the distal open ends of the elastomeric sleeve and the disinfection cap, defines a fourth orifice for exposing the distal surface of the elastomeric sleeve to the distal open end of the disinfection cap, the disinfection pad defining a distal end surface adapted to disinfect the patient connector when the disinfection cap is coupled to the connector; The translation of the spiked end of the end cap pierces the elastomeric sleeve, enabling direct fluid communication between the inlet of the end cap and the distal open end of the sterilization cap.

2. The apparatus of claim 1 further includes a selectively engaging locking mechanism that connects the distal end wall of the guide housing to the proximal end wall of the sterilization cap.

3. The device according to claim 2 further includes the distal end wall of the guide housing and the proximal end wall of the sterilization cap nested together and slidably engaged, wherein selective engagement and disengagement are facilitated by engagement and disengagement of the locking mechanism.

4. The device according to claim 3, wherein the selectively engaging locking mechanism comprises a torsion connector.

5. The device according to claim 4, wherein the torsion connector includes at least one snap pin formed on the guide housing or the sterilization cap and a corresponding receiver slot formed on the other of the guide housing or the sterilization cap.

6. The device according to claim 5, wherein at least one receiver slot has a T-shaped profile, an L-shaped profile, or a J-shaped profile, including a snap pin 124 on the sterilization cap 46 and a J-shaped receiver slot 150 formed in the guide housing.

7. The device according to claim 1, wherein the guide housing and the sterilization cap are permanently connected to each other.

8. The device of claim 1, wherein the elastomeric sleeve has a peripheral flange abutting against the proximal end wall of the sterilizing cap and a hollow tubular rod portion protruding into a second cavity for receiving the shaft of the end cap, wherein the distal end of the tubular rod is pierced by the spiked end.

9. The apparatus of claim 8, further comprising the tubular rod having an expandable bellows configured to expand axially when the shaft of the end cap is inserted therein.

10. The apparatus according to claim 1, wherein, The guide housing has a cover with its distal end coupled to the housing, and the proximal end of the cover protruding axially away from the proximal end of the housing in a first position and displaced away from the proximal end of the housing in a second position, thereby preventing the end cap from moving forward within a first internal cavity of the guide housing when the cover is in its first position, but allowing the forward movement when the cover is in its second position, such forward movement enabling the spiked tip of the end cap to pierce the elastomeric sleeve.

11. The apparatus of claim 1, further comprising a sheet peeling cap covering the distal open end of the sterilization cap.

12. The device according to claim 1, wherein the disinfection pad further comprises an antimicrobial material.

13. The apparatus according to claim 12, wherein, The disinfection pad is compressible when the disinfection cap is attached to the patient connector.

14. The apparatus of claim 1, wherein the first Luer connector and / or the second Luer connector comprises a threaded Luer connector.

15. A system for disinfecting and flushing intravenous patient connectors, comprising: A guide housing having an inner first circumferential wall surface, a proximal end wall defining a first through-hole therein, a distal end wall defining a second through-hole therein, and a first internal cavity defined within the first circumferential wall surface and the corresponding proximal and distal end walls. An end cap, which is confined within the first internal cavity and is translatable within the first internal cavity, the proximal end of the end cap defining an inlet and a first Luer connector, the distal end of the end cap defining a shaft with a spiked end, the shaft defining an outlet and an internal lumen in fluid communication with the inlet and outlet of the end cap; A disinfection cap having an inner second circumferential wall surface, a proximal end wall defining a third through-hole for receiving the end cap, and a distal open end, the second circumferential wall surface defining a second Luer connector; The corresponding first cavity and second cavity are aligned with each other, so that the tip of the end cap can be translated into the second cavity within the third through hole; An elastomeric sleeve, confined within a second internal cavity, having a proximal surface and a distal surface, the proximal surface being pierced by the tip of a spike as the end cap undergoes axial translation through the third through-hole, the distal surface facing the open distal end of the sterilization cap; and A disinfection pad, which is confined within a second internal cavity, between the distal open ends of the elastomeric sleeve and the disinfection cap, defines a fourth orifice for exposing the distal surface of the elastomeric sleeve to the distal open end of the disinfection cap, the disinfection pad defining the distal end surface; A pre-filled flushing syringe having a syringe barrel containing a flushing solution, a plunger capable of translation within the syringe barrel, and a third Luer connector inserted through a first through-hole of the guide housing and coupled to a first Luer connector of an end cap, the inlet of the end cap being in fluid communication with the flushing solution contained within the syringe barrel; as well as A patient connector, the patient connector including a connector body defining a fourth Luer connector, the fourth Luer connector being coupled to a second Luer connector within the sterilization cap, wherein the distal end surface of the sterilization pad contacts the fourth Luer connector; The flushing syringe is moved forward into the first cavity, causing the spiked end of the end cap to translate, piercing the elastomeric sleeve and allowing the flushing solution to flow fluidly between the flushing syringe and the patient connector via the inlet, internal lumen, and outlet of the end cap, and wherein the forward movement of the translational plunger dispenses the flushing solution into the patient connector.

16. The system of claim 15, further comprising a selectively engaging locking mechanism that connects the distal end wall of the guide housing to the proximal end wall of the sterilization cap for selectively separating the guide housing and the flushing syringe from the sterilization cap.

17. The system of claim 16, wherein the selectively engaging locking mechanism comprises a torsion connector.

18. The system of claim 17, wherein the torsion connector includes at least one snap pin formed on the guide housing or the sterilization cap and a corresponding receiver slot formed on the other of the guide housing or the sterilization cap.

19. The system of claim 18, wherein at least one receiver slot has a T-shaped or L-shaped profile for facilitating selective separation of the guide housing and the flushing syringe from the disinfection cap when the guide housing is twisted relative to the disinfection cap in a first direction, and for removing the disinfection cap together with the guide housing and the flushing syringe from the patient connector when the guide housing is twisted relative to the disinfection cap in a second direction.

20. The system of claim 18, wherein at least one receiver slot has a J-shaped profile for selectively separating the guide housing and the flushing syringe from the disinfection cap when the guide housing is twisted relative to the disinfection cap in a first direction, such that the disinfection cap remains connected to the patient connector.

21. The system of claim 15, wherein the guide housing and the sterilization cap are permanently coupled to each other such that detachment of the sterilization cap from the patient connector separates the entire system from the patient connector.

22. The system according to claim 15, wherein, The guide housing has a cap, the distal end of which is coupled to the housing, and the proximal end of the cap protrudes axially away from the proximal end of the housing in a first position and is displaced away from the proximal end of the housing in a second position, thereby preventing the syringe and the coupled end cap from moving forward within a first internal cavity of the guide housing when the cap is in its first position, but allowing the forward movement when the cap is in its second position, such forward movement enabling the spiked tip of the end cap to pierce the elastomeric sleeve.

23. The system of claim 15 further includes a sheet peeling cap covering the distal open end of the sterilization cap.

24. The system of claim 15, wherein the disinfection pad further comprises an antimicrobial material.

25. The system of claim 25 further includes a compressible sterilization pad that is compressed when the sterilization cap is attached to the patient connector.

26. The system of claim 15, wherein the corresponding pair of interconnected first Luer connectors and third Luer connectors and / or the corresponding pair of interconnected second Luer connectors and fourth Luer connectors comprise threaded Luer connectors.

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