MEDICAL SPONGE FOR CATHETER SYSTEMS

Abstract

The present disclosure generally relates to systems and medical sponge for cleaning needleless connectors. A medical sponge can include a shaped foam configured to engage a portion of the needless connector and a disinfecting solution applied to the shaped foam. A system can include the medical sponge and a liquid-impermeable pouch in which the medical sponge is separately retained. The medical sponge can include highly-abrasive and highly-conforming foam material in place of wipes or other sponge products. The foam material may be an open-cell micro abrasive material such as melamine foam. The foam material may contain disinfecting solutions such as isopropyl alcohol, chlorhexidine gluconate, or povidone-iodine.

Description

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. Non-Provisional patent application Ser. No. 16/206,002 filed Nov. 30, 2018, which is a continuation of U.S. Non-Provisional patent application Ser. No. 15/498,447, filed Apr. 26, 2017 and patented as U.S. Pat. No. 10,166,085, which claims the benefit, under 35 U.S.C. § 119(e), of U.S. Provisional Patent Application No. 62/327,470, filed Apr. 26, 2016, the contents and substance of which is incorporated herein by reference in its entirety as if fully set forth below.

FIELD OF INVENTION

The present disclosure relates to medical sponge, and more particularly, to an apparatus and method for cleaning needleless connectors, also referred to as ports, in central venous catheter (CVC) systems (also known as central line systems).

BACKGROUND

The development of needleless intravenous (IV) administrative systems began in the 1990s to protect against the spread of blood-borne diseases contracted from needle stick injuries by utilizing a threaded needleless connector. To administer medication to a patient from a syringe or IV bag, a healthcare professional must connect a threaded portion of the syringe or IV bag to a corresponding threaded portion of the needleless connector for the medication to flow through the needleless connector and into the patient. IV systems evolved to include multiple needleless connectors allowing multiple medications to be administered to the patient without using needles or needing to disconnect existing connections, thus simplifying medication administration by healthcare professionals and reducing patient discomfort.

Unfortunately, improper cleaning of these needleless connectors can result in harmful pathogens, such as bacteria, growing around the needleless connector. This growth may be referred to as biofilm. Moreover, when medication is administered, a portion of the pathogen (or associated biofilm) may be inadvertently transferred into the patient's bloodstream and may result in an infection. The resulting infection is known as a bloodstream infection (BSI).

When a patient develops a BSI in an intensive care unit (ICU), the resulting infection may be life-threatening. Protocols, such as the “Scrub the Hub” protocol issued by the Centers for Disease Control (CDC), try to mitigate these infections by recommending that the needleless connectors be scrubbed for at least 15 seconds using alcohol wipes. However, the effectiveness of this approach is limited.

One limitation is that adherence to the recommend 15 seconds of scrubbing is not strictly monitored and often leads to some healthcare professionals scrubbing for less time, resulting in inconsistent or improper cleaning of the needleless connector.

Another limitation is that, even if healthcare professionals scrub the needleless connector for at least 15 seconds, the scrubbing must be done thoroughly to ensure proper cleaning of the threads, grooves, septum, or other intricate features where biofilm can develop.

For example, while scrubbing using an alcohol wipe, sufficient pressure needs be applied to remove biofilm from the needleless connector. Since alcohol wipes do not provide an indication when sufficient pressure is being applied, healthcare professionals have to guess whether or not they have applied enough pressure. Moreover, alcohol wipes do not conform to a surface when pressure is applied, so healthcare professionals must manually shape the wipe and rely on their dexterity to ensure thorough cleaning of the needleless connector's intricate features.

Attempts have been made to replace wipes with cleaning products or caps that use a foam material. Such products use a semi-closed hydrophilic polyurethane medical grade foam. Prior attempts to utilize foam for cleaning needleless connectors have been unsuccessful at being a viable replacement for wipes. Such foam-based products are designed for cleaning female luers wherein the hydrophilic polyurethane foam is encased in a housing with an open end for inserting female luers. Therefore, such prior designs are not effective at cleaning all needleless connectors. For example, the prior foam-based designs are not successful in cleaning conventional open lumen stopcock device rims compared to wipes according to, for example, Holroyd et. al., “Universal intravenous access cleaning device fails to sterilize stopcocks,” Anesth Analg. 2014 February; 118(2):333-43. Additionally, prior foam-based devices are not a viable alternative to wipes because they are significantly more expensive than wipes. These and other disadvantages exist.

There is a need for a more robust medical sponge for cleaning needleless connectors that is more robust to operator error, better conforms to intricate features, and provides an indication that sufficient pressure is applied.

SUMMARY

Embodiments of the disclosed technology include systems, methods, and equipment for cleaning needleless connectors by reducing inconsistent cleaning caused by operator error.

Some embodiments disclosed comprise a medical sponge including an open-cell microabrasive foam, such as, for example, formaldehyde-melamine-sodium-bisulfite foam (i.e., “melamine foam”). The present disclosure also relates to methods for cleaning a needleless connector that include, in some embodiments, scrubbing the needleless connector in a twisting motion with the medical sponge that has a disinfecting solution applied.

In some embodiments, the medical sponge may be configured to provide audible feedback to a user when the user scrubs a needleless connector with the medical sponge in a twisting motion with an appropriate force to remove a biofilm that may be present on the needleless connector.

In some embodiments, the foam material may have no linear dimension greater than 3 centimeters. The medical sponge may be disposable and packaged in a liquid-impermeable pouch, and the pouch may be scored or provide some means for being easily torn open during use. The disinfecting solution may contain a 70% isopropyl alcohol solution and may further contain a chlorhexideine solution, a povidone-iodine solution, or both.

The medical sponge material may have a block or cube shape. Alternatively, the medical sponge may have a cylindrical shape with a hollow center and an open end such that the medical sponge is configured to be put over the top of a needleless connector or other system ports (similar to how a cap might be placed over a port) wherein the hollow center of the medical sponge has the appropriate dimensions to fit over the needleless connector or port. For example, given standard dimensions of a needleless connector, a cylindrical hollow center of the medical sponge having a diameter of at least 7 millimeters but not more than 8 millimeters may be capable of fitting over a needleless connector.

Additional features and advantages are realized through the techniques of the present disclosure. Other embodiments and aspects of the disclosed technology are described in detail herein and are considered a part of the claimed embodiments. For a better understanding of the disclosed embodiments with the advantages and the features, refer to the description and the drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A and 1B depict an example medical sponge, according to some embodiments of the present disclosure.

FIGS. 2A and 2B depict an example medical sponge, according to some embodiments of the present disclosure.

FIGS. 3A, 3B, and 3C illustrate usage of an example medical sponge according to some embodiments of the present disclosure.

FIG. 4 illustrates data comparing the use of an example medical sponge according to some embodiments of the present disclosure versus the use of a wipe.

DETAILED DESCRIPTION

Although example embodiments of the present disclosure are explained in detail herein, it is to be understood that other embodiments are contemplated. Accordingly, it is not intended that the present disclosure be limited in its scope to the details of construction and arrangement of components set forth in the following description or illustrated in the drawings. The present disclosure is capable of other embodiments and of being practiced or carried out in various ways.

It must also be noted that, as used in the specification and the appended claims, the singular forms “a,” “an” and “the” include plural referents unless the context clearly dictates otherwise. Ranges may be expressed herein as from “about” or “approximately” one particular value and/or to “about” or “approximately” another particular value. When such a range is expressed, other exemplary embodiments include from the one particular value and/or to the other particular value.

By “comprising” or “containing” or “including” is meant that at least the named compound, element, particle, or method step is present in the composition or article or method, but does not exclude the presence of other compounds, materials, particles, method steps, even if the other such compounds, material, particles, method steps have the same function as what is named.

As used herein, the term “medical sponge” may refer to a scrubber or a foam scrubber.

As used herein, the term “needless connector” may refer to a CVC system port (i.e., system port, or port), a CVC catheter hub (i.e., hub), luer, similar medical equipment, or small-bore connections in hypodermic application of medical devices and accessories, such as system port 150, is standardized under ISO 80369-7:2016.

In describing example embodiments, terminology will be resorted to for the sake of clarity. It is intended that each term contemplates its broadest meaning as understood by those skilled in the art and includes all technical equivalents that operate in a similar manner to accomplish a similar purpose. It is also to be understood that the mention of one or more steps of a method does not preclude the presence of additional method steps or intervening method steps between those steps expressly identified. Steps of a method may be performed in a different order than those described herein without departing from the scope of the present disclosure. Similarly, it is also to be understood that the mention of one or more components in a device or system does not preclude the presence of additional components or intervening components between those components expressly identified.

Embodiments of the disclosed technology include systems, methods, and apparatus for cleaning needleless connectors. In particular, certain embodiments provide an apparatus and a method for a low-cost, highly abrasive, medical sponge for cleaning a variety of IV system ports in a shortened period of time compared to existing methods.

Certain embodiments include a medical sponge composed of formaldehyde-melamine-sodium-bisulfite foam, also known as melamine foam, that is impregnated with a disinfecting solution. As will be appreciated, melamine foam has several advantages over wipes that are typically used for cleaning needleless connectors. Melamine foam is more abrasive and thereby more effective at removing biofilms through friction, meaning that needleless connectors may be disinfected in a shorter scrubbing time compared to wipes. Melamine foam is fiberless and thereby will not leave behind fibers like a wipe typically used in this application. Melamine foam is highly conformal and therefore more effective at cleaning small crevices such as needleless connector threads. Melamine foam has an open cell structure that allows for capillary forces to draw pathogens up and away from the surface of a needleless connector, whereas a wipe may spread around and leave behind material. When melamine foam is applied to a needleless connector with a twisting motion producing sufficient friction force to remove biofilms, the frictional force generates an auditory feedback, “squeak”, that informs the user that biofilms are being removed. Additionally, the cost of a medical sponge composed of melamine foam is comparable in price to a wipe typically used to clean needleless connectors, and in some embodiments, may be capable of cleaning the variety of needleless connectors. A medical sponge composed of melamine foam is therefore a viable and more effective replacement to a wipe.

Melamine foam has several advantages over semi-closed hydrophilic polyurethane foam. Unlike hydrophilic polyurethane foam, melamine foam is more abrasive, more conformal, thus allowing for greater diversity in cleaning needleless connectors and components, and provides auditory feedback during proper use.

FIGS. 1A, 1B, 2A, and 2B illustrate various embodiments of medical sponge 100 that are composed of a highly conforming, abrasive, and porous foam material that is impregnated with a disinfecting solution, according to the present disclosure. FIGS. 1A and 1B show an example embodiment of a medical sponge 100 having a cylindrical shape with a hollow center 105, a closed end 110, an open end 120, and a length 125. The medical sponge 100 is designed to fit over a needleless connector 150 such that when in use, the medical sponge 100 can be configured to make simultaneous contact with the sides and top of the port 150. Currently, the size of small-bore connections in hypodermic application of medical devices and accessories, such as needleless connector 150, is standardized under ISO 80369-7:2016. Accordingly, the present disclosure contemplates that the diameter of the hollow center 105 and the length 125 may be designed to accommodate needleless connectors 150 meeting the ISO standard.

In other embodiments, such as shown in FIGS. 2A and 2B, the medical sponge 100 may have a cube or block shape. The block shape may be sized to provide an ergonomic hand grip. For example, the Human Engineering Design Data Digest issued by the Department of Defense Human Factors Engineering Technical Advisory Group in Washington D.C. issued April 2000 indicates a medical sponge sized approximately two centimeters in height and/or length may provide an ergonomic fit to hand grip. And tests indicate that a medical sponge 100 sized between two and three centimeters in height and length provides the proper ergonomics to properly clean a needleless connector.

In certain use cases, a technician or other user of embodiments of the disclosed medical sponge (e.g., 100 of FIG. 1A, 1B, 2A, or 2B) may press the medical sponge 100 against the needleless connector 150 in a manner resulting in conformal contact between the medical sponge 100 and the sides and the top of the port 150. Embodiments can be configured such that a user can twist the medical sponge 100 around the sides of the needleless connector 150 and that the medical sponge 100 can be scrubbed against the top of the needleless connector 150 during use. As will be appreciated, the form-fitting characteristics of the scrubbing device 100 can allow the needleless connector 150 to be cleaned, particularly the threads and the septum. As will be appreciated further, the highly abrasive foam material, in conjunction with the disinfecting solution that is impregnated within the foam material can clean the needleless connector 150 and remove bacteria.

FIGS. 3A, 3B, and 3C show usage of an example medical sponge (e.g., 100) according to some embodiments. As shown in FIG. 3A, in some embodiments, a medical sponge 100 can be packaged within a liquid impermeable package 305. The user may open the package 305 by tearing along a scored line 310, for example. Once open, the user can extract the medical sponge 100 from the package 305 and apply the medical sponge 100 to a needleless connector 150 in a twisting motion, drawing pathogens into the medical sponge 100 as shown in FIG. 3B. Once cleaning is complete, the medical sponge 100 containing the pathogens can be discarded in a trash bin as shown in FIG. 3C. As will be appreciated, various embodiments of a medical sponge 100 having a block shape as depicted in FIGS. 2A and 2B, a cylindrical shape as depicted in FIGS. 1A and 1B, or some other shape may be used in the manner shown in FIGS. 3A, 3B, and 3C.

FIG. 4 illustrates data from tests using example embodiments of a melamine medical sponge containing a 70% isopropyl alcohol (IPA) solution, as indicated by the “BioSCRUB” data points, and data from using non-woven IPA prep pads. Initial tests of present embodiments indicate the medical sponge foam material may remove at least 50% more Escherichia coli from a needless connector compared to a non-woven IPA prep pad used under identical STH conditions.

Claims

1-20. (canceled)

21. A medical sponge for cleaning a needleless connector, the medical sponge comprising:

a shaped foam configured to engage a portion of a needleless connector; and

a disinfecting solution applied to the shaped foam.

22. The medical sponge of claim 21, wherein the shaped foam has a substantially rectangular shape.

23. The medical sponge of claim 21, wherein the medical sponge has a height between about 2 cm and about 3 cm and a length between about 2 cm and about 3 cm.

24. The medical sponge of claim 21, wherein the shaped foam has an open-cell structure.

25. The medical sponge of claim 24, wherein the open-cell structure of the shaped foam allows for capillary forces to draw pathogens away from the surface of the needleless connector.

26. The medical sponge of claim 21, wherein the shaped foam includes formaldehyde-melamine-sodium-bisulfate.

27. The medical sponge of claim 21, wherein the medical sponge is sufficiently abrasive to produce audible feedback when twisted on a portion of the needleless connector.

28. The medical sponge of claim 27, wherein the audible feedback is generated by a frictional force between the medical sponge and a portion of the needleless connector, thereby indicating sufficient frictional force is being generated.

29. The medical sponge of claim 21, wherein the medical sponge is a single use accessory.

30. The medical sponge of claim 21, wherein the disinfecting solution is at least one of: 70% isopropyl alcohol, Povidone-Iodine, or Chlorhexidine gluconate.

31. The medical sponge of claim 21, wherein the medical sponge is configured to be twisted around a portion of the needleless connector.

32. The medical sponge of claim 21, wherein the medical sponge conforms to at least a portion of the needleless connector.

33. The medical sponge of claim 21, wherein the medical sponge is configured to simultaneously contact with sides and top of the needleless connector.

34. A system for cleaning a needleless connector comprising:

the medical sponge of claim 21; and

a liquid-impermeable pouch, wherein the medical sponge is separably retained within the liquid-impermeable pouch.

35. A system for cleaning a needless connector, the system comprising:

a medical sponge configured to engage a threaded portion of the needleless connector;

a disinfecting solution applied to the medical sponge; and

a liquid-impermeable pouch, wherein the medical sponge is separably retained within the liquid-impermeable pouch.

36. The system of claim 35, wherein the medical sponge is sufficiently abrasive to produce audible feedback when twisted on a portion of the needleless connector.

37. The system of claim 36, wherein the audible feedback is generated by a frictional force between the medical sponge and a portion of the needleless connector, thereby indicating sufficient frictional force is being generated.

38. The system of claim 35, wherein the medical sponge comprises a foam having an open-cell structure.

39. The system of claim 38, wherein open-cell structure allows for capillary forces to draw pathogens away from the surface of the needleless connector.

40. The system of claim 35, wherein the medical sponge is configured to be conformal to at least a portion of the needleless connector.