Patent Application
20240285926
The present disclosure generally relates to a device for disinfecting and sterilizing access ports with, e.g., male and/or female Luer fittings, and, in particular, to disinfecting and sterilizing devices capable of accommodating multiple types of Luer connectors. Generally, exemplary embodiments of the present disclosure relate to the fields of threaded fitting, including medical caps and medical disinfection caps, and in particular universal application medical caps and/or disinfection caps for uses with either or both of male and female, fluid Luer connectors.
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. Bacteria and other microorganisms may gain entry into a patient's vascular system from access hubs and ports/valves upon connection to the VAD to deliver the fluid or pharmaceutical. Each access hub (or port/valve or 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 early indications are that caps will also be incorporated into the 2016 Infusion Nurses Standards (INS) guidelines.
In developed markets, when utilizing an IV catheter, a needleless connector will typically be used to close off the system and then subsequently 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.” However, compliance to this practice is typically very low. In addition to a lack of compliance to “scrubbing the hub”, it has also been noted through clinician interviews that there is often a variation in scrub time, dry time and the number of times the needleless connector is scrubbed.
Throughout the sequence of procedures associated with the transmission of a microorganism that can cause a CRBSI, there are many risks of contact or contamination. Contamination can occur during drug mixing, attachment of a cannula, and insertion into the access hub. Because the procedure to connect to a VAD is so common and simple, the risk associated with entry into a patient's vascular system has often been overlooked. Presently, the risk to hospitals and patients is a substantial function of the diligence of the clinician performing the connection, and this diligence is largely uncontrollable.
Currently, caps for male needleless connectors, female needleless connectors, intravenous (IV), and hemodialysis lines use different designs and are, therefore, limited to the types of connectors to which the cap can be attached. Currently, there are male disinfecting cap devices for disinfecting ISO594-2 type of female threaded fluid luer connectors and there are female disinfecting cap devices for disinfecting ISO594-2 type of male threaded fluid luer connectors. Thus, prior disinfecting caps were designed to fit one type of connector only, and were specific to one particular size and/or shape of connector.
U.S. Pat. No. 11,511,100 discloses a singular universal disinfecting cap device with features allowing it to interface with either a male or female type of threaded connectors.
Referring to
Embodiments of the disclosure pertain to a universal cap for connection to and disinfection of a medical connector, including male connectors and female connectors. The universal cap embodiments disclosed herein facilitate easier cap alignment and engagement with threaded male or female Luer medical connectors and enhanced connector disinfection. A split-collar protrusion projects axially from a closed end wall of the cap towards the open bottom and comprises at least an opposed pair of parallel, sector-shaped, collet fingers/prongs that terminate in protrusion tips. Some cap embodiments have more than two collet fingers/prongs. The inner wall of each collet finger/prong of the split-collar protrusion respectively defines a split-flange cantilever. Each split flange has a flange root that is coupled to its corresponding inner wall, from which projects an axial contact surface that terminates in a flange tip. Collectively, the respective flange tips of the split flanges are in radially inwardly opposed orientation with respect to an axial centerline of the split-collar protrusion, and commonly oriented axially along the protrusion inner wall, intermediate the closed end wall and the protrusion tips. While two collet fingers/prongs 61 are shown in this cap 50 embodiment, other embodiments incorporate more than two of them. Inner and outer walls of each collet finger/prong respectively define split inner and outer threads, which are respectively sized for mating engagement with respective corresponding female and male threads of Luer connectors. An absorbent material is oriented between the split flanges and the cap bottom. In some embodiments, the absorbent material is infused with an antimicrobial agent. As the cap is affixed to a Luer connector, compression of the absorbent material biases the split flanges toward the cap end wall and deflects the tips of the collet fingers/prongs radially inwardly, toward the cap's axial centerline, for easier cap alignment and engagement with the corresponding connector and enhanced connector disinfection. The exemplary cap disclosed herein provides a mechanical barrier for medical connectors and retains the antimicrobial agent for disinfection. The cap of the present disclosure allows the medical practitioner to streamline the disinfection process by simplifying cap/connector engagement while simultaneously disinfecting the connector.
One aspect of the present disclosure pertains to a cap for coupling to a male or female Luer medical connector. The cap comprises a housing having an axial centerline. The cap defines a first cavity formed within a housing top wall and a circumscribing housing sidewall. The cavity is in communication with an open bottom of the housing. A split-collar protrusion is oriented within the first cavity, coupled to the top wall, circumscribing the axial centerline and projecting toward the open bottom. This protrusion has a plurality of opposed, parallel, sector-shaped, collet prongs, also referred to as collet fingers. Each respective collet finger/prong has a distal protrusion tip and a protrusion outer wall surface, which defines outer wall split threads that are sized and adapted for mating engagement with corresponding collar threads of a male Luer connector. Each respective collet finger/prong also has an inner wall surface defining inner wall split threads that are sized and adapted for mating engagement with corresponding threads of a female Luer connector. The respective inner wall split threads and the respective outer wall split threads start at the distal protrusion tip and terminate proximate the top wall. The respective inner surfaces of the collet prongs define a second cavity sized and adapted for receipt of a male or a female Luer connector. A split flange is coupled to the inner wall surface of each respective collet prong by a flange root, intermediate the inner split threads and the top wall. Each separate, respective split flange has a cantilever-like, distal axial contact surface that is commonly oriented radially inwardly with respect to the axial centerline of the housing and terminates in a flange tip that is radially opposed to the other flange tips. An absorbent material is interposed within the second cavity, between the respective split flanges and the open bottom of the housing, The absorbent material compresses during advancement of a male or a female Luer connector within the second cavity and biases the split flanges toward the top wall of the housing. The now biased split flanges deflect the protrusion tip of its respective collet prong inwardly toward the axial centerline of the housing.
This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. Additional features and advantages of the disclosure are set forth in the description, below and in the appended claims.
Exemplary embodiments of the disclosure are further described in the following detailed description in conjunction with the accompanying drawings, in which:
To facilitate understanding, identical reference numerals have been used, where possible, to designate identical elements that are common to the figures. The figures are not drawn to scale.
Embodiments of the disclosure pertain to a universal cap for connection to and disinfection of a medical connector, including male connectors and female connectors. In some embodiments, the male connectors and female connectors are threaded male and female Luer connectors. The universal cap embodiments disclosed herein facilitate casier cap alignment and engagement with threaded male or female Luer medical connectors and enhanced connector disinfection. A split-collar protrusion projects axially from a closed end wall of the cap towards the open bottom and comprises at least an opposed pair of parallel, sector-shaped, collet fingers/prongs that terminate in protrusion tips. The inner wall of each collet finger respectively defines a split-flange cantilever. Inner and outer walls of each collet finger define split threads, which are respectively sized for mating engagement with respective corresponding threads of Luer connectors. An absorbent material is oriented between the split flanges and the cap bottom. In some embodiments, the absorbent material is infused with an antimicrobial agent. As the cap is affixed to a Luer connector, compression of the absorbent material biases the split flanges toward the cap end wall and deflects the collet fingers/prongs radially inwardly, toward the cap's axial centerline, for easier cap alignment and engagement with the connector and enhanced connector disinfection. The exemplary cap disclosed herein provides a mechanical barrier for medical connectors and retains the antimicrobial agent for disinfection. The cap of the present disclosure allows the medical practitioner to streamline the disinfection process by simplifying cap/connector engagement while simultaneously disinfecting the connector.
In this disclosure, where generally applicable, a convention is generally followed wherein the distal end of the device is the end closest to a patient, and the proximal end of the device is the end away from the patient and closest to a clinician or other medical practitioner. Thus, with respect to the universal caps disclosed herein, the open end of the cap that connects to a male or female Luer connector is referred to as its distal end while the closed end of the cap is referred to as its proximal end. As used herein, the use of “a,” “an,” and “the” includes the singular and plural.
As used herein, the term “catheter related bloodstream infection” or “CRBSI” refers to any infection resulting from the presence of a catheter or IV line.
As used herein, the term “Luer connector” refers to a connection collar that is the standard way of attaching syringes, catheters, hubbed needles, IV tubes, etc. to each other. The Luer connector consists of male and female interlocking tubes, slightly tapered to hold together better with even just a simple pressure/twist fit. Luer connectors can optionally include an additional outer rim of threading, allowing them to be more secure. The Luer connector male end is generally associated with a flush syringe and can interlock and connect to the female end located on the vascular access device (VAD). A Luer connector comprises a distal end, a proximal end, an irregularly shaped outer wall, a profiled center passageway for fluid communication from the chamber of the barrel of a syringe to the hub of a VAD. A Luer connector also has a distal end channel that releasably attaches the Luer connector to the hub of a VAD, and a proximal end channel that releasably attaches the Luer connector to the barrel of a syringe.
As would be readily appreciated by skilled artisans in the relevant art, while descriptive terms such as “lock”, “tip”, “hub”, “thread”, “sponge”, “prong”, “protrusion”, “wall”, “top”, “side”, “bottom” and others are used throughout this specification to facilitate understanding, it is not intended to limit any components that can be used in combinations or individually to implement various aspects of the embodiments of the present disclosure.
As used herein, the term “medical device” refers to common medical devices having threaded or interlocking connections, the connections having corresponding mating elements. By way of example but not limitation, a syringe may have a male threaded connection which releasably interlocks with a secondary medical device such as a male luer connection of a catheter, an IV line and the like. The threaded connection may include a lumen defining a fluid path surrounded by a protruding wall having the threaded means for attaching to the secondary medical device.
As would be readily appreciated by skilled artisans in the relevant art, while descriptive terms such as “thread”, “taper”, “tab”, “slant”, “wall”, “top”, “side”, “bottom” and others are used throughout this specification to facilitate understanding, it is not intended to limit any components that can be used in combinations or individually to implement various aspects of the embodiments of the present disclosure.
The matters exemplified in this description are provided to assist in a comprehensive understanding of exemplary embodiments of the disclosure. Accordingly, those of ordinary skill in the art will recognize that various changes and modifications of the embodiments described herein can be made without departing from the scope and spirit of the disclosure. Also, descriptions of well-known functions and constructions are omitted for clarity and conciseness.
Exemplary embodiments of the present disclosure provide caps that can reduce the number of device types and logistics currently needed in the hospital setting for connecting, capping, and/or disinfecting male and female threaded fluid luer connectors, by roughly half by including in a single cap or device features allowing it to be use with both male needleless connectors and female needleless connectors.
According to still further exemplary implementations of the embodiments of the present disclosure, female threads are sized and have a thread pattern that will engage with a standard ISO594-2 type of male fitting and/or male threads that are sized and have a thread pattern that will engage with a standard ISO594-2 type of female fitting. An example of an ISO594-2 type of fitting is a Q-style fitting.
In one or more embodiments, the female needless connector may be selected from the group consisting essentially of needle-free connectors, catheter luer connectors, stopcocks, and hemodialysis connectors. In one or more embodiments, the needleless connector is selected from a Q-Syte connector, MaxPlus, MaxPlus Clear, MaxZero, UltraSite, Caresite, In Vision-Plus, Safeline, OneLink, V-Link, ClearLink, NeutraClear, Clave, MicroClave, MicroClave Clear, Neutron, NanoClave, Kendall, Nexus, In Vision, Vadsite, Bionector, etc.
In one or more embodiments, the male connector may be an intravenous tubing end, a stopcock or male lock luer.
Before describing several exemplary embodiments of the disclosure, it is to be understood that the disclosure is not limited to the details of construction or process steps set forth in the following description. The disclosure is capable of other embodiments and of being practiced or being carried out in various ways.
The matters exemplified in this description are provided to assist in a comprehensive understanding of exemplary embodiments of the disclosure. Accordingly, those of ordinary skill in the art will recognize that various changes and modifications of the embodiments described herein can be made without departing from the scope and spirit of the disclosure. Also, descriptions of well-known functions and constructions are omitted for clarity and conciseness.
Referring to
Each collet finger/prong 61 defines a protrusion inner wall 68 and a cantilevered split flange 70. Each split flange 70 has a flange root 71 that is coupled to its corresponding protrusion inner wall 68, from which projects a distal, axial contact surface 72 that terminates in a flange tip 73. Collectively, the respective flange tips 73 of the split flanges 70 are in radially inwardly opposed orientation with respect to an axial centerline of the split-collar protrusion 60, and commonly oriented radially along the protrusion inner wall, intermediate the closed top wall 60 and the protrusion tips 62. While two collet fingers/prongs 61 are shown in this cap 50 embodiment, other embodiments incorporate more than two collet fingers.
Collectively, the collet fingers/prongs 61 define a circular planform, about an axial centerline, as shown in
A cylindrically shaped, absorbent material 80, having a proximal axial surface 82, is interposed within the inner, second cavity 76, retained by radial compression and friction engagement with the female Luer engageable split threads 74. The absorbent material 80 abuts the axial contact surface 72 of each of the split flanges 70. In one or more embodiments, the absorbent material 80 is a nonwoven material, foam, or a sponge. In a specific embodiment, the foam is a polyurethane foam. In a specific embodiment the absorbent material 80 is in the form of a foam plug. In yet another exemplary implementation, a disinfecting member or members, such as an absorbent material 80, in the form of an IPA-soaked sponge and/or sponge.
The cap 50 can disinfect Luer connectors by integrating disinfectant or antimicrobial agent in the absorbent material 80. In some embodiments, the disinfectant or antimicrobial agent is directly included in the inner, cylindrical-shaped cavity 76 and/or the outer, annularly shaped cavity 78. In other embodiments, disinfectant or antimicrobial agent is absorbed into sponges or foam material comprising the absorbent material 80. Cap 50 is compatible in interacting with various disinfectants. In one or more embodiments, the disinfectant or antimicrobial agent includes variations of alcohol or chlorhexidine. In one or more embodiments, the disinfectant or antimicrobial agent is selected from the group consisting essentially of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, t-butyl-hydroquinone, chloroxylenol, chlorohexidine, chlorhexidine diacetate, chlorohexidine gluconate, povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotic, and mixtures thereof. In a specific embodiment, the disinfectant or antimicrobial agent comprises at least one of chlorhexidine gluconate and chlorhexidine diacetate. In one or more embodiments, the disinfectant or antimicrobial agent is a fluid or a gel.
Compression of the absorbent material 80, toward the closed end wall 56 of housing 52 upon connection to a female Luer connector or the male Luer connector allows the connector to contact the disinfectant or antimicrobial agent to disinfect the connector. Thus, compression of the absorbent material 80 while coupling the cap 50 to a Luer connector disinfects the connector.
Referring to
In
In addition to improving cap 50 and male IV connector 90 engagement tolerances and/or interference fit reduction for enhanced component mating, the cap embodiments disclosed herein also enhance disinfection of the tapered, male Luer portion 92 during cap engagement. As the male IV connector is inserted within the cap 50 and the insertion force Fc deflects the split flanges 70, the distal axial surface 82 of the compressing sponge 80 biases against the proximal tip 94, rollover edge 96 and upper adjoining circumferential outer surface 97 of the tapered, male Luer portion 92, scrubbing them with disinfectant retained within the sponge. As the cap 50 and the male IV connector 90 are screwed together, additional circular scrubbing action further disinfects the tapered, male Luer portion 92.
In
Therefore, the same universal cap 50 of the present disclosure, with its split-collar protrusion 60, facilitates easier cap alignment, engagement with and enhanced disinfection of male Luer connectors, such as the male IV connector 90 of
In various embodiments, the cap 50 of the present disclosure is constructed from any of a number of types of plastic materials such as polycarbonate, polypropylene, polyethylene, glycol-modified polyethylene terephthalate, acrylonitrile butadiene styrene or any other injection-moldable, medical-grade, plastic material used in medical devices. In one or more embodiments, the cap 50 comprises a polypropylene or polyethylene material. In some embodiments, the cap 50 is a monolithic structure. In some embodiments, the cap 50 is a monolithic structure, constructed of medical grade plastic. In some embodiments, the cap 50 is formed by an injection molding process. In some embodiments, the housing sidewall 54 and the closed top or end wall 56 of the housing 52 are of unitary construction and the split-collar protrusion 60, including collet fingers/prongs 61 are of separate, unitary construction, with both unitary components affixed to each other by heat or friction welding, adhesive or mechanical staking/fastening.
Reference throughout this specification to “one embodiment,” “certain embodiments,” “various embodiments.” “one or more embodiments” or “an embodiment” means that a particular feature, structure, material, or characteristic described in connection with the embodiment is included in at least one embodiment of the disclosure. Thus, the appearances of the phrases such as “in one or more embodiments,” “in certain embodiments,” “in various embodiments,” “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily referring to the same embodiment of the disclosure. Furthermore, the particular features, structures, materials, or characteristics may be combined in any suitable manner in one or more embodiments.
Although the disclosure herein provided a description with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the disclosure. It will be apparent to those skilled in the art that various modifications and variations can be made to the present disclosure without departing from the spirit and scope thereof. Thus, it is intended that the present disclosure include modifications and variations that are within the scope of the appended claims and their equivalents.
