Device male port cleaner

The present invention includes a device male port cleaner, and method of use, for cleaning a male port connector, particularly a male port connector for a medical device. The device male port cleaner may be connected to the male port connector to clean and/or disinfect the male port connector.

BACKGROUND OF THE INVENTION

Field of the Invention

The present invention relates to device male ports, and more particularly to an apparatus and a method for cleaning and/or decontaminating device male ports, including medical device male ports.

Description of the Related Art

When treating patients in the medical field, there is a need to prevent the transmission of pathogens into or onto a patient from a potentially contaminated surface of a medical implement, or “site” when infusing fluids or aspiration of fluids to or from a patient. Such pathogens include microorganisms such as bacteria and viruses. The transmission of pathogens into a patient may result in an infection that could be life threatening. Contamination by microorganisms may occur via extrinsic or intrinsic contamination. Extrinsic contamination may occur when preparing or administering medications via vascular access systems. Intrinsic contamination may occur during the manufacturing of the device or medication. Extrinsic contamination may be derived from many possible sources including entry points in the administration sets as well as intravenous line connections between different intravenous sets. Other sources for contamination may include during compound medication preparation, improper use of equipment, improper temperature control, improper sterilization/preparation techniques, or methods.

An important aspect in preventing infections as related to connectors includes the constant change of dressings and careful attention to maintaining hygienic and aseptic access to the connector. Traditionally, cleaning a potentially contaminated surface includes a protocol of alcohol swabbing prior to making the necessary connections to the site. However, a poorly swabbed site can carry microorganisms that, if allowed to enter a patient's body, can cause serious harm. Sometimes, much of medical implements used may be so small that it may be difficult to properly cleanse all portions of the implement, particularly the connecting portions of medical device ports. Even more difficult is the ability to clean the interior surface of device ports that are difficult to access. Therefore, it is desired to provide a cleaning device that is simple, economical to manufacture, and effective in cleaning the interior and exterior surface of device ports, particularly medical device male ports.

SUMMARY

Provided is a device male port cleaner, and method of use, for cleaning a device male port that may be inserted into the device male port cleaner.

DETAILED DESCRIPTION OF THE INVENTION

In the following discussion, numerous specific details are set forth to provide a thorough understanding of the present invention. However, those skilled in the art will appreciate that the present invention may be practiced without such specific details. In other instances, certain specific details, and the like have been omitted inasmuch as such details are not considered necessary to obtain a complete understanding of the present invention, and are considered to be within the understanding of persons of ordinary skill in the relevant art.

InFIGS. 1-12, a device male port cleaner100with a device cap200is shown. In an embodiment, the device male port cleaner100may be coupled to a male port connector to coat the male port connector with an antimicrobial disinfecting solution for disinfection. Prior to being used, the device cap200may be secured over the device male port cleaner100to seal and protect the connecting end of the device male port cleaner100from contamination and other environmental hazards.

Turning toFIGS. 1 and 2, an embodiment of the device male port cleaner100and the device cap200is shown. According to the embodiment inFIG. 1, the device male port cleaner100may comprise a distal end2and a proximal end4. The distal end2may further comprise a handle10for gripping the cleaner100by the user. The handle10may further comprise grooves12for traction when handling the cleaner100. The proximal end4of the cleaner100may comprise the connecting portion of the cleaner100with a female luer14being used to connect the device male port cleaner100to male port connectors needing to be cleaned. The female luer14may further comprise a luer lock16for securing the cleaner100to the outer encasing of male port connector being cleaned. The device male port cleaner100may further comprise a flange18formed between the handle10and the female luer14. The flange18may comprise a circular ring structure formed around the outer circumference of the cleaner100and curving outwards away from the outer surface of a transition area between the handle10and the female luer14. The flange18may curve outwards as it extends away from the outer surface of the cleaner100resembling much of a skirt looped around the cleaner100. When the female luer14is connected to a male port connector for cleaning, the flange18may contact an outer casing of the male port connector to form a seal around the female luer14and the inner portions of the male port connector. The seal formed by the flange18and the outer casing of the male port connector may aid in preventing contamination during the cleaning of the male port connector and maintain its sterility after.

Each of the components making up the device male port cleaner100may be made of various semi-rigid to rigid materials, including plastic, aluminum, polymer, stainless steel, silicone based material, synthetic isoprene, isoprene, and thermoplastics. This listing is illustrative, only, and not intended to be exhaustive. It should be appreciated by one skilled in the art that a wide range of materials or mixtures of materials, with properties similar to the above-listed materials may be used to construct the device male port cleaner100. In alternative embodiments, the device male port cleaner100may be provided with additional, fewer, or different components that those of the embodiment shown. For example, in an embodiment, two or more of the components of the cleaner100may be combined within a single component, such as the handle10and the flange12, female luer14and luer lock16, or the handle10and the female luer14. Alternatively, for ease of manufacturing, the entire cleaner100and all of its components may also be formed as a single unitary structure.

In an embodiment, as shown inFIG. 2, the device cap200may be secured to the device male port cleaner100to prevent contamination of the connecting portion of the cleaner100prior to use. The device cap200may be secured over the proximal end4of the cleaner100to encase the female luer14within a sealed environment to maintain its sterility. When the device cap200is secured to the cleaner100, the opening edge202of the device cap200may be coupled with the outer edge26of the flange18to create a seal around the proximal end4and the female lure14of the device male port cleaner100. The device cap200may operate to minimize contamination as well as protect the proximal end4of the cleaner100prior to use. The outer edge26of the flange18may be substantially the same shape and size, or slightly larger than the opening edge292of the device cap200such that when the two surfaces are coupled together, a seal may be created between the flange18and the device cap200. The device cap200may be made of various semi-rigid to rigid materials, including plastic, aluminum, polymer, stainless steel, silicone based material, synthetic isoprene, isoprene, and thermoplastics. This listing is illustrative, only, and not intended to be exhaustive. It should be appreciated by one skilled in the art that a wide range of materials or mixtures of materials, with properties similar to the above-listed materials may be used to construct the device cap200.

Turning toFIGS. 3 and 4, the device male port cleaner100may also comprise a reservoir20that starts from an opening28in the female luer14at the proximal end4of the cleaner100. The reservoir20may then extend internally within the cleaner100towards the distal end2within the handle10. The shape of the cutout in the device male port cleaner100for the reservoir20may include but is not limited to a cylinder, a prism, a rectangular prism, a triangular prism, a tube, a pyramid, and the like. The reservoir20may further contain at least one of an absorbent material22and a disinfecting agent24. The absorbent material22may be soaked in the disinfecting agent24prior to use to absorb and hold the disinfecting agent24within the reservoir20.

24. As shown inFIGS. 5 and 10, the absorbent material22may be secured within the reservoir20such that the absorbent material22remains compressible. Compressing the absorbent material22may act as a release mechanism for releasing and dispersing the disinfecting agent24being held by the absorbent material22. The absorbent material22may be sized and shaped to fit within the reservoir20such that the absorbent material22may match the corresponding shape of the cutout used for forming the reservoir20. The absorbent material22may be formed from any absorbent, porous, and compressible material including but not limited to a sponge, absorbent cotton, polyurethane, polyvinyl alcohol, silicone, cellulose wood fibers, foam, and foamed plastic polymers.FIG. 4shows that when the device cap200is secured to the device male port cleaner100, the absorbent material22and the disinfecting agent24are sealed within the reservoir20to be protected from contaminants and environmental hazards. The reservoir20may therefore be sized to substantially fit both a male port connector to be inserted into the reservoir20and the absorbent material22once compressed and the disinfecting agent24released.

The reservoir20may also contain the disinfecting agent24only without the use of the absorbent material22. The disinfecting agent24may be used for cleaning connecting ports inserted into the device male port cleaner100. In an embodiment, the disinfecting agent24may be any antimicrobial or antiseptic agent including but not limited to isopropyl alcohol, povidine iodine, and the like. The disinfecting agent24may also be in a liquid, gel, or hydrogel form with various viscosities. The disinfecting agent24may be initially contained within the absorbent material22before being released or sealed within the reservoir20of the device male port cleaner100until exposed to a male connecting port inserted into the device male port cleaner100.

As shown inFIG. 1, the luer lock16may further comprise various threading features and designs along the outer surface of the female luer14to enable the device male port cleaner100to be secured by being threaded into the male port connector intending to be cleaned. The threading features may be formed by curves planes extending diagonally around the circumference and outer surface of the female luer14. The luer lock16may also comprise an opening30that extends through the female luer14to enable the disinfecting agent24when dispersed to also flow out and coat the outer surface of the luer lock16. With the outer surface of the luer lock16also exposed to the disinfecting agent24, the threading movement to secure the cleaner100to the male port connector for cleaning may further disperse and contact the disinfecting agent24along the interior surfaces of the connector. The threading of the disinfecting agent24coated luer lock16within the connector may aid in cleaning the connector's interior threaded surfaces. In addition to the embodiment shown, the threading features along the luer lock16may be adjusted to various shapes, sizes, and designs to complement the various male port connectors known to one skilled in the art and that the device male port cleaner100may be used with. In an alternative embodiment, the luer lock16may not comprise any threading at all. As shown inFIGS. 3 and 4, the device cap200may also further comprise threading along the interior surface of the device cap200so that the device cap200may also be threaded over the luer lock16and the female luer14when being secured to the cleaner100. The threading along the interior of the device cap200may aid in ensuring that the device male port cleaner100is sealed for sterility, and that the device cap200is firmly secured to the device male port cleaner100and protected prior to use.

The device male port cleaner100may be used to clean various male connecting port connectors related to and including medical device ports such as needle ports, luer locks, catheter hubs, and threaded male connectors used with infusion therapies such as but not limited to intravenous lines, pharmaceuticals, chemotherapeutic drugs, supplements, and intrathecal. Turning toFIGS. 6 and 7, in an embodiment, the device male port cleaner100may be connected to a male port connector300to disinfect the male port connector300. The device male port cleaner100may be gripped at the handle10by a user as shown inFIG. 6and threaded into the male port connector300as shown inFIG. 7. The handle10may comprise grooves12that aid in creating traction for gripping and the handling the cleaner100. The grooves12may be periodically spaced around the circumference of the outer surface of the handle10. The grooves12may be of various sizes and depth depending on the overall size of the device male port cleaner100. The handle10may comprise various numbers of grooves12including 1, 2, 3, 4, etc. The handle10may also not have any grooves12at all. The device male port cleaner100may be secured to the male port connector300by threading the luer lock16against the interior surfaces of the outer casing310of the male port connector300. The device male port cleaner100and the male port connector300may be coupled together until the flange18of the cleaner100contacts the edge of the outer casing310of the connector300. The coupling of the flange18and the outer casing310may create a seal to maintain the sterility of the male port connector300being cleaned by the cleaner100prior to use, and to prevent the loss of the disinfecting agent24released by the cleaner100.

Turning toFIGS. 8A and 8B, the device male port cleaner100and the male port connector300may be operatively connected to disinfect the connector300as well as maintain its sterility. An interlocking mechanism between the cleaner100and the connector300enables a male plug312of the connector300to be inserted into the cleaner100for cleaning as well as create a seal to prevent contamination of the connector300after cleaning. When the cleaner100is being secured to the connector300to disinfect the connector300, as shown inFIG. 9, the connecting of the cleaner100to the connector300may comprise an interlocking mechanism such that when the luer lock16of the cleaner100is threaded into the outer casing310of the connector300, the male plug312of the connector300may be simultaneously inserted into the female luer14of the cleaner100and into the reservoir20. The device male port cleaner100may be threaded into the male port connector300until the flange18contacts the outer casing310of the connector300, as shown inFIG. 8B. The enclosure created by the flange18and the outer casing310may aid in keeping the male plug312sterile prior to being used and minimize contamination. When the male port connector300is ready to be used, the cleaner100may then be removed to free the male port connector300for use.

FIGS. 9 and 10show that in an embodiment, when the device male port cleaner is threaded into the connector300, the male plug312of the connector is inserted into the reservoir20to contact and compress the absorbent material22. Turning toFIG. 10, when the absorbent material24is compressed by the male plug312inside the reservoir20of the cleaner100, the compression of the absorbent material22acts as a release mechanism for the disinfecting agent24. Once released from the absorbent material22, the disinfecting agent24may then proceed to clean and disinfect the male plug312. The compression of the male plug312against the absorbent material22to release the disinfecting agent24occurs simultaneously as the cleaner100is being threaded into the connector300. Once the male plug312begins to enter the reservoir20as the cleaner100is being threaded into the connector300, the released disinfecting agent24inside the reservoir20may also flow out of reservoir20thorough the opening30in the luer lock16and be dispersed throughout the interior surface of the outer casing310. The threading of the luer lock16against the interior surface of the outer casing310to connect the cleaner100may aid in dispersing the disinfecting agent24throughout the internally threaded skirt of the outer casing310.FIG. 9shows the disinfecting agent24flowing through the opening30as the cleaner is being threaded may also be dispersed and clean the region32of the connector300. In an alternative embodiment, the reservoir20may contain only the disinfecting agent24contained by a seal. The disinfecting agent24may then be released by the male plug312being inserted into the reservoir and breaking the seal.

FIGS. 11A-11C, andFIG. 12show the device male port cleaner100being threaded onto the male port connector300to disinfect the connector300and then removed to free the connector300. InFIG. 11A, prior to the cleaner100being used to clean the connector300, the absorbent material22within the reservoir20of the cleaner100is uncompressed and therefore relatively fills the reservoir20. The absorbent material22may be sized so as not to fit the reservoir20too tight when uncompressed. This may then leave additional room for the male plug312to be relatively easily inserted into the reservoir20and the absorbent material22compressed, as shown inFIG. 11B, when cleaning the connector300. After cleaning the male port connector300using the device male port cleaner100, the cleaner may remain secured to the connector300prior to the connector300being used. This may aid in maintaining the sterility of the connector300and minimize contamination after cleaning the connector300with the cleaner100but prior to use.FIG. 12shows that the cleaner100may be threaded into the male port connector300to clean the connector until the flange18contacts the outer casing310of the connector300. The flange18creates a seal with the outer casing310to maintain sterility of the male plug312as well as prevent leakage of the disinfecting agent24.

Having thus described the present invention by reference to certain of its exemplary embodiments, it is noted that the embodiments disclosed are illustrative rather than limiting in nature and that a wide range of variations, modifications, changes, and substitutions are contemplated in the foregoing disclosure and, in some instances, some features of the present invention may be employed without a corresponding use of the other features. Many such variations and modifications may be considered desirable by those skilled in the art based upon a review of the foregoing description of exemplary embodiments. Accordingly, it is appropriate that any claims supported by this description be construed broadly and in a manner consistent with the scope of the invention.