ABRASIVE SCRUBBER FOR PORTS IN CENTRAL VENOUS CATHETER SYSTEMS

Abstract

The present disclosure generally relates to systems for disinfecting Central Venous Catheter (CVC) system ports that use highly-abrasive and highly-conforming foam material in place of wipes or other sponge products, and methods for using such systems. The foam material may be an open-cell microabrasive material such as melamine foam. The foam material may contain disinfecting solutions such as isopropyl alcohol, chlorhexidine gluconate, or povidone-iodine.

Claims

1. A foam scrubber comprising: a formaldehyde-melamine-sodium-bisulfite foam material, the foam material having no linear dimension greater than 3 centimeters; a disinfecting solution retained within the foam material, the disinfecting solution formulated for disinfecting a central venous catheter (CVC) catheter hub, wherein the foam scrubber is configured to produce an audible feedback to a user of the foam scrubber when the user applies the scrubber to the CVC catheter hub in a twisting motion, the audible feedback indicating that the user is applying sufficient force to remove a biofilm present on the CVC catheter hub.

2. The foam scrubber of claim 1, wherein the foam scrubber is packaged in a liquid-impermeable pouch, and wherein the pouch is configured to be torn open by only by the user's hands.

3. The foam scrubber of claim 1, wherein the disinfecting solution comprises a 70% isopropyl alcohol solution.

4. The foam scrubber of claim 3, wherein the disinfecting solution further comprises a chlorhexidine gluconate solution, a povidone-iodine solution, or both.

5. The foam scrubber of claim 1, the foam material having a cube or block shape.

6. The foam scrubber of claim 1, the foam material having a cylindrical shape with a hollow center, an open end allowing access to the hollow center, and a closed end.

7. The foam scrubber of claim 6, the hollow center having a cylindrical shape with a diameter large enough to accommodate insertion of a CVC needleless connector hub into the hollow center, and the open end having an opening large enough to accommodate insertion of the CVC needleless connector hub into the hollow center.

8. The foam scrubber of claim 6, the hollow center having a cylindrical shape with a diameter of at least 7 millimeters and not more than 8 millimeters.

9. The foam scrubber of claim 1, wherein the foam scrubber is disposable.

10. A method for disinfecting a Central Venous Catheter (CVC) system port, the method comprising scrubbing the CVC system port in a twisting motion with a formaldehyde-melamine-sodium-bisulfite foam material, wherein the foam material contains a disinfecting solution.

11. The method of claim 10, wherein during the scrubbing, a friction force between the foam material and the CVC system port generates an audible feedback to a user, the audible feedback providing an indication that the scrubbing is resulting in a friction force between the foam material and the CVC system port capable of removing a biofilm on the CVC system port.

12. The method of claim 10, wherein the disinfecting solution contains at least one of a 70% isopropyl alcohol solution, a chlorhexidine gluconate solution, or a povidone-iodine solution.

13. The method of claim 10, wherein the CVC system port is a CVC catheter hub.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0017] The subject matter which is regarded as the invention is particularly pointed out and distinctly claimed in the claims at the conclusion of the specification. The forgoing and other features and advantages of the disclosed embodiments are apparent from the following detailed description taken in conjunction with the accompanying drawings in which:

[0018] FIGS. 1A and 1B depict an example scrubber, according to some embodiments of the present disclosure.

[0019] FIGS. 2A and 2B depict an example scrubber, according to some embodiments of the present disclosure.

[0020] FIGS. 3A, 3B, and 3C illustrate usage of an example scrubber according to some embodiments of the present disclosure.

[0021] FIG. 4 illustrates data comparing the use of an example scrubber according to some embodiments of the present disclosure versus the use of a wipe.

DETAILED DESCRIPTION

[0022] 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.

[0023] 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.

[0024] 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.

[0025] 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.

[0026] Certain embodiments of the disclosed technology provide an apparatus and method for properly cleaning medical equipment according to prescribed guidelines. In particular, certain embodiments provide an apparatus and a method for a low-cost, highly abrasive, foam scrubber for disinfecting a variety of IV system ports in a shortened period of time compared to existing methods.

[0027] Certain embodiments include a scrubber 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 CVC system ports. Melamine foam is more abrasive and thereby more effective at removing biofilms through friction, meaning that CVC system ports can 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 luer threads. Melamine foam has an open cell structure that allows for capillary forces to draw infectious agents up and away from the surface of a CVC system port, whereas a wipe may spread around and leave behind material. When melamine foam is applied to a system port 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 scrubber composed of melamine foam is comparable in price to a wipe typically used to clean CVC system ports, and in some embodiments, may be capable of cleaning the variety of CVC system ports. A scrubber composed of melamine foam is therefore a viable and more effective replacement to a wipe.

[0028] 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 system ports 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 CVC system ports. For example, the prior foam-based designs are not successful in disinfecting 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. 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 CVC system ports and components, and provides an auditory feedback during proper use.

[0029] Despite the advantages of melamine foam described above, melamine is not commonly used in medical devices. One explanation for the continued use of wipes in cleaning medical devices is the broad applicability of wipes in cleaning applications. In addition to medical devices, wipes can be used, for example, to disinfect skin. Melamine foam, however, is not as biocompatible as wipes. So while melamine foam is a viable replacement for wipes in the application of cleaning CVC system ports, due to the abrasive nature of melamine foam, it may not be a viable solution for other applications in which wipes are used such as, for example, cleaning skin.

[0030] FIGS. 1A, 1B, 2A, and 2B illustrate various embodiments of scrubbers 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 scrubber 100 having a cylindrical shape with a hollow center 105, a closed end 110, an open end 120, and a length 125. The scrubber 100 is designed to fit over a system port 150 such that when in use, the scrubber 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 system port 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 system ports 150 meeting the ISO standard.

[0031] In other embodiments, such as shown in FIGS. 2A and 2B, the scrubber 100 may have a simple 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 scrubber sized approximately two centimeters in height and/or length may provide an ergonomic fit to hand grip. And tests indicate that a scrubber 100 sized between two and three centimeters in height and length provides the proper ergonomics to properly clean a CVC system port.

[0032] In certain use cases, a technician or other user of embodiments of the disclosed scrubber (e.g., 100 of FIG. 1A, 1B, 2A, or 2B) may press the scrubber 100 against the system port 150 in a manner resulting in conformal contact between the scrubber 100 and the sides and the top of the port 150. Embodiments can be configured such that a user can twist the scrubber 100 around the sides of the port 150 and that the scrubber 100 can be scrubbed against the top of the port 150 during use. As will be appreciated, the form-fitting characteristics of the scrubbing device 100 can allow the entire system port 150 to be cleaned, particularly the luer 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 material can sanitize the system port 10 and remove any bacteria.

[0033] FIGS. 3A, 3B, and 3C show usage of an example scrubber (e.g., 100) according to some embodiments. As shown in FIG. 3A, in some embodiments, a scrubber 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 scrubber 100 from the package 305 and apply the scrubber 100 to a system port 150 in a twisting motion, drawing any infectious agents into the scrubber 100 as shown in FIG. 3B. Once sanitation is complete, the scrubber 100 containing the infectious agents can be discarded in a trash bin as shown in FIG. 3C. As will be appreciated, various embodiments of a scrubber 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.

[0034] FIG. 4 illustrates data from tests using example embodiments of a melamine foam scrubber 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 scrubber foam material may remove at least 50% more Escherichia coli from a connector hub compared to a non-woven IPA prep pad used under identical STH conditions.