Invented by Thomas F. Fangrow, ICU Medical Inc

The market for sanitizing caps for medical connectors has witnessed significant growth in recent years. With the increasing focus on patient safety and infection control, healthcare facilities are adopting stringent measures to prevent the spread of infections. Sanitizing caps play a crucial role in maintaining the cleanliness and sterility of medical connectors, thereby reducing the risk of healthcare-associated infections (HAIs). Medical connectors are widely used in various healthcare settings, including hospitals, clinics, and ambulatory care centers. These connectors are used to join different medical devices and equipment, such as intravenous (IV) lines, catheters, and syringes. However, these connectors can become a breeding ground for bacteria and other pathogens if not properly cleaned and maintained. Sanitizing caps are designed to cover and protect medical connectors when they are not in use. These caps are typically made of antimicrobial materials that inhibit the growth of bacteria and other microorganisms. By covering the connectors, sanitizing caps prevent the entry of contaminants, ensuring that the connectors remain clean and sterile until they are used again. The demand for sanitizing caps has been driven by the increasing prevalence of HAIs and the growing emphasis on infection prevention in healthcare settings. According to the Centers for Disease Control and Prevention (CDC), HAIs affect millions of patients worldwide and result in significant morbidity, mortality, and healthcare costs. Infections acquired in healthcare settings are a major concern for both patients and healthcare providers, leading to a greater focus on infection control measures. Sanitizing caps offer a simple yet effective solution to prevent the spread of infections through medical connectors. These caps are easy to use and can be quickly applied to connectors, providing an additional layer of protection. They are available in various sizes and designs to fit different types of connectors, ensuring compatibility with a wide range of medical devices. In addition to infection prevention, sanitizing caps also offer other benefits. They help reduce the risk of accidental contamination during handling and transportation of medical devices. Moreover, these caps can also serve as a visual indicator, signaling that a connector has been properly cleaned and is ready for use. The market for sanitizing caps for medical connectors is highly competitive, with several manufacturers offering a wide range of products. These caps are typically sold through medical supply distributors and online platforms, making them easily accessible to healthcare facilities. Manufacturers are constantly innovating to develop caps with improved antimicrobial properties, ease of use, and compatibility with different types of connectors. In conclusion, the market for sanitizing caps for medical connectors is witnessing significant growth due to the increasing focus on infection prevention in healthcare settings. These caps play a vital role in maintaining the cleanliness and sterility of medical connectors, thereby reducing the risk of HAIs. With the rising demand for patient safety and infection control, the market for sanitizing caps is expected to continue its upward trajectory in the coming years.

The ICU Medical Inc invention works as follows

Herein are disclosed “Antiseptic Caps that can be used for disinfecting and/or protecting medical connectors.” In certain embodiments, an antiseptic cap may include a chamber that can be removed from the connector. Also disclosed are delivery systems that can be used with medical articles. The delivery system may include antiseptic cap holders and/or dispensing systems. The delivery system may be configured in some embodiments to allow the medical articles from the system to be removed individually.

Background for Sanitizing Caps for Medical Connectors

Field of Invention

This invention relates specifically to antiseptic caps that can be used with medical connectors.

Certain embodiments disclosed in this document relate to caps for connectors used in medical applications, and more specifically to caps that are used to disinfect and to prevent contamination of medical connectors which have not been connected. These connectors may include connectors used for fluid delivery systems or fluid flow.

Description of Related Art

Catheters can be used for a wide range of medical procedures. Catheters are either acute or temporary for short-term or long-term treatments. Catheters can be inserted from peripheral veins into central veins, such as the venacava. This allows access to a patient?s vascular system.

The medical industry uses standardized Luer-taper fittings for “Catheter Connections” such as connecting catheters to the dialysis machine tubing or to the IV line tubing. They also use them to connect catheters to the infusion ports, and to prevent fluid leakage and/or contamination. These fittings can be either male or female couplings and have a standard tapered end. Press-fitting of mating pieces is used to make coupling. To ensure that the Luer fittings are pressure-fitted, a threaded lock or another type of locking mechanism is often used. Other non-standard fittings can also be used to couple components selectively.

Catheter related bloodstream infections (CRBSI), which are caused by microorganisms entering a patient’s system via intravascular catheters can cause unnecessary illness, complications and excessive medical costs. In the United States, a large number of these infections occur each year in intensive care units.

Antimicrobial agents are one way to reduce these infections. However, many of these catheters do not provide satisfactory results. “Some microbes are resistant to the antimicrobial agents that were used in the catheters.

It has been determined that antiseptic caps such as those manufactured and sold under the SWABCAP trademark by Excelsior, reduce the risk of infection, leading to, among other benefits, significant savings for patients, and a better quality of life. There is still a need for other cap designs that can be used with different medical connectors and fittings.

Disclosed are disinfecting caps which can reduce the risk of microorganisms infecting the bloodstream of patients via fluid flow systems or fluid-delivery devices, such as medical connectors, injection sites without needles and/or medical liquid transfer devices. In some embodiments one or several caps can be configured to work with a medical system that has one or multiple luer connectors. For example, a female or a male medical connector with a luer fit. In certain embodiments, the cap comprises a base, and a liquid dispensing material (such as an absorbent) that is configured for carrying a therapeutic liquid, gel or antiseptic agent, such a liquid gel or antiseptic agent.

Different embodiments of caps for medical use can incorporate different systems, components, and methods. The accompanying figures illustrate some embodiments. However, they are only provided as a convenience for illustration and are not intended to limit inventions to any particular combination of features. Any feature, structure or material, any step or component, of an embodiment described or illustrated in the specification may be used alone, with other features, structures, materials, steps or components of another embodiment described or illustrated in the specification, or in combination or replacement of other features, structures, materials, steps or components. This specification does not include anything that is necessary or essential. “Any of the devices, connections, or features described or illustrated anywhere in this specifications can be configured to either attach to, protect, or sanitize medical fluid connectors that comply with ISO standard 80369 or ISO standard 594, or to comply with any industry standard applicable to such connectors.

Overview

This disclosure is about embodiments of a cap that can be disinfected and/or protected medical connectors. A cap can be used to cover intravascular connectors that are associated with a fluid path, such as an I.V. line. The references in this application to connectors (e.g. a male luer) should be understood as including and disclosing any type medical implement which facilitates the storage, transfer or connection of fluid lines or medical fluids (e.g. any open or resealable connector for fluid lines, syringes, catheter connectors, vials, vial adapters, pump cartridges or disposables, pharmaceutical compounding components, female connectors, blood-line connections, IV bags, catheter

Fluid pathways can provide direct access into a patient’s circulation and be used to administer medication intermittently. The fluid pathways may have associated medical connectors which can be connected with other connectors. In certain embodiments, the corresponding connectors may have male or feminine connection regions. These can be male or woman luer connections or luer locks. The connection regions provide a convenient method to connect and disconnect the fluid pathway. One or more caps, such as luer caps, can be used to protect connectors that are not connected from contamination when the connectors have connection regions. Caps that contain or carry an antiseptic can be beneficial for disinfecting the connection region of a connector (e.g. a luer-connection region) prior to sealing it off from contamination. The structure, step or material that is described and/or illustrated in any embodiment of this specification may be substituted for any other structure or step or material or component described and/or illustrated in another embodiment. “No structure, material or component is necessary or essential.

Antiseptic Cap

FIGS. The antiseptic cap 82 is shown in various views, 1A-1H. In particular, FIG. FIG. FIGS. 1B-1F show the antiseptic caps 82 in FIG. FIGS. FIGS. 1A includes an antiseptic 86. Referencing numerals are used in FIGS. 1A-1H are components that are similar or identical to those in the other figures. The antiseptic cap shown in FIGS. The antiseptic cap 82 shown in FIGS. It is also understood that any embodiment described or contemplated in this document can be modified so as to be used with antiseptic cap 8 shown in FIGS. 1A-1H.

As shown in FIGS. The antiseptic cap can have a first chamber. The first chamber can be configured for removably attachment to a connector. In some embodiments, for instance, the interior surface 87 of the first chamber can be configured to interact, among other things, with a portion or feature of a connector. For example, a connector’s end, or one or several threads. The interior surface 87 of some embodiments can be threadless, and have any suitable texture. For example, it could be smooth or rough. In certain embodiments, a first chamber 84 may be pushed or twisted on and/or removed from a portion of the medical connector. In certain embodiments, the diameter 84D1 on the interior surface 87 is shown in FIG. The antiseptic cap and medical connector can be interacted with by having a 1F that is essentially the size of, or just slightly smaller or larger than the diameter of the outer surface. At least a part of the interior surface can be configured so that it slides over a portion on the medical connector where the cap is intended to attach. This encourages the interior surface to expand, stretch, or move in a resilient or elastomeric manner to accept the portion for attachment. In some embodiments the section of interior surface 87 which contacts the portion of medical connector is smooth enough to allow attachment between the cap and the connector when a user pushes it with an axially directed force. The magnitude of this force is low enough to allow repeated attachment and detachment of caps and connectors during a working day without causing undue strain to the user. The first chamber 84 can have a diameter of 84D1 large enough to engage a connector. For example, the connector may be snugly and/or securely engaged to prevent unintentional removal. As shown in FIGS. 1A-1F the first chamber diameter may be slightly smaller that a diameter of an inner flange, 123D2. The diameter 84D1 can also be adjusted to fit a smaller connector. In some embodiments the first chamber can have multiple diameters. However, it is also contemplated that first chamber 84 could have a single diameter as shown in FIGS. 1A-1F. The medical connector can be of any shape or configuration that is compatible with the interior surface of the antiseptic caps 82. In some embodiments the medical connector may include threads, rough surfaces, ridges or ribs.

In some embodiments, to facilitate the attachment of the antiseptic caps 82 to the medical connectors, it is possible for the antiseptic caps 82 comprise a semi rigid material that can deform when a force is applied. The interior surface of the antiseptic caps 82 can be deformed temporarily or permanently when it interacts with a medical connector. In certain embodiments, antiseptic caps 82 may be made of a rigid material which is sufficiently flexible to allow the interior surface to engage with the medical connector. In certain embodiments, an interface can be formed between the medical connector 82 and the antiseptic cap. The fluid tight seal that forms when the antiseptic caps 82 are attached to the medical connector can function as a barrier to isolate a portion of first chamber 84. In some embodiments, a fluid tight seal may be configured in such a way that it prevents an antiseptic agent or contaminants from entering confined portion of first chamber 84. The interior surface 87’s ability to deform allows the cap 82, which is removably connected to a connector by means of threads, to be attached without using them. In some embodiments, for example, the semi-rigid materials can be configured so that threads from a medical connector slide into the chamber 84, causing the interior surface to deform radially inward when the threads are sliding in. In some embodiments the interior surface can be configured so that it bounces radially back inwards after the threads slide into the first chamber. The interior surface 87 of the antiseptic 82 can be configured to deform in a radially outward direction wherever the medical connect interacts with it. A threadless antiseptic (e.g. antiseptic 82) cap can be configured in a way that allows it to accept one or more connectors with different characteristics (e.g. threads of various sizes, connectors of different threads).

As shown in FIGS. The first chamber 84 may be configured to receive or house any feature suitable. In some embodiments, for example, the first compartment 84 may be configured to accommodate a liquid dispenser, such as an absorptive material 86, (as shown on FIGS. The first chamber 84 can be configured to house a liquid-dispenser, such as an absorbent material 86 (as shown in FIGS. In some embodiments, for example, the absorbent material can be placed in the first chamber. The depth 84L1 of the first chamber 84 may be sized appropriately to accommodate the absorbent material. The first chamber can be any suitable shape or configuration that is capable of receiving an appropriate portion of a connector. As shown in FIGS. As shown in FIGS. It will be understood that in some embodiments the second chamber 85 may consist of a shallow depression.

The first chamber 84 may have any depth suitable 84L1 as shown in FIGS. The first chamber 84 can comprise any suitable depth 84L1, shown in FIGS. The depth 84L1, as shown in FIG. The depth 84L1, shown in FIG. In certain embodiments, depth 84L1 may be less that one-half of the length of the antiseptic caps 82L1, while still being sufficiently receded to house the absorbent materials 86. It will be understood that the first 84 chamber can have any shape or configuration suitable for receiving and/or containing the absorbent material. The depth 84L1 may, for example, be greater than half the length 82L1 the antiseptic cap.

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