Disinfection device containing chlorhexidine-based solution

Abstract

The present invention relates to a disinfection device comprising a container containing a chlorhexidine-based solution having a chlorhexidine concentration of 0.2-2.0% by weight / volume. Also provided is a medical connector sterilized with the sterilization device. The invention also discloses a method for sterilizing the medical connector by using the sterilizing device.

Description

[0001] Cross - reference to related applications

[0002] This application claims the priority of U.S. Invention Application No. 17 / 979,165, filed on November 2, 2022, with the invention title "Disinfecting Device Containing Chlorhexidine - Based Solution", the entire disclosure of which is incorporated herein by reference in its entirety. Technical field

[0003] The present invention relates to a disinfecting device containing a chlorhexidine - based solution. Background art

[0004] Disinfecting devices can be used to disinfect medical connectors (such as intravenous catheter connectors) for use on patients. Disinfecting devices can include a disinfecting cap or a scrubbing device. Isopropyl alcohol (IPA) is commonly used as the disinfecting substance in these disinfecting devices. However, while IPA properly disinfects the connector, it evaporates within seconds and does not leave a persistent disinfecting substance on the connector. Thus, after the evaporation of IPA, the connector is at risk of being contaminated before use and may be contaminated. Summary of the invention

[0005] Disclosed herein is a disinfecting device including a container containing a chlorhexidine - based solution having a chlorhexidine concentration of 0.2 - 2.0% weight / volume.

[0006] Also disclosed herein is a disinfected medical connector, which includes a medical connector disinfected with the disinfecting device described herein.

[0007] Also disclosed herein is a method of disinfecting a medical connector, which includes contacting the medical connector with a chlorhexidine - based solution having a chlorhexidine concentration of 0.2 - 2.0% weight / volume contained in a container of the disinfecting device.

[0008] According to one embodiment of the present invention, the disinfecting device has a container containing a chlorhexidine - based solution including a chlorhexidine concentration of 0.2 - 2.0% weight / volume.

[0009] According to one embodiment of the present invention, the chlorhexidine concentration is 0.4 - 1.5% weight / volume or 0.5 - 1.0% weight / volume.

[0010] According to one embodiment of the present invention, the chlorhexidine - based solution contains chlorhexidine acetate and / or chlorhexidine gluconate.

[0011] According to one embodiment of the present invention, the chlorhexidine-based solution comprises isopropyl alcohol.

[0012] According to one embodiment of the present invention, the chlorhexidine-based solution comprises an isopropyl alcohol concentration of at least 25% weight / volume or at least 50% weight / volume.

[0013] According to one embodiment of the present invention, the disinfection device comprises a disinfection cap or a disinfection washing device.

[0014] According to one embodiment of the present invention, the disinfection device is configured to engage with a medical connector.

[0015] According to one embodiment of the present invention, the medical connector comprises a needleless connector, a male connector, and / or a stop cock.

[0016] According to one embodiment of the present invention, the disinfection device is sterilized.

[0017] According to one embodiment of the present invention, the disinfection device is sterilized using steam sterilization, an autoclave, and / or radiation sterilization.

[0018] According to one embodiment of the present invention, the chlorhexidine-based solution comprises oil.

[0019] According to one embodiment of the present invention, the disinfected medical connector comprises a medical connector disinfected with the disinfection device as described herein.

[0020] According to one embodiment of the present invention, the disinfection device comprises a disinfection cap that engages with a medical connector.

[0021] According to one embodiment of the present invention, the disinfection device comprises a washing device containing a chlorhexidine-based solution, and the medical connector is immersed in the solution.

[0022] According to one embodiment of the present invention, the method of disinfecting a medical connector comprises contacting the medical connector with a chlorhexidine-based solution having a chlorhexidine concentration of 0.2 - 2.0% weight / volume contained in a container of the disinfection device.

[0023] According to one embodiment of the present invention, the chlorhexidine-based solution comprises an isopropyl alcohol concentration of at least 25% weight / volume or at least 50% weight / volume.

[0024] According to one embodiment of the present invention, the sterilization of the disinfection device occurs by using steam sterilization, an autoclave, and / or radiation sterilization.

[0025] According to an embodiment of the present invention, the disinfection solution comprises a chlorhexidine-based solution, which contains a chlorhexidine concentration of 0.2 - 2.0% weight / volume.

[0026] According to an embodiment of the present invention, the chlorhexidine concentration is 0.4 - 1.5% weight / volume or 0.5 - 1.0% weight / volume.

[0027] According to an embodiment of the present invention, the chlorhexidine-based solution contains chlorhexidine acetate and / or chlorhexidine gluconate.

[0028] According to an embodiment of the present invention, the chlorhexidine-based solution includes isopropyl alcohol.

[0029] According to an embodiment of the present invention, the chlorhexidine-based solution includes an isopropyl alcohol concentration of at least 25% weight / volume or at least 50% weight / volume.

[0030] According to an embodiment of the present invention, the chlorhexidine-based solution includes oil. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Figure 1 Schematic diagram of a disinfection device according to a non-limiting embodiment described herein;

[0032] Figure 2 Schematic diagram of a disinfection device in the form of a cap according to a non-limiting embodiment described herein; and

[0033] Figure 3 Schematic diagram of a disinfection device in the form of a washing device according to a non-limiting embodiment described herein. DETAILED DESCRIPTION

[0034] The following description is provided to enable a person skilled in the art to make and use the described embodiments contemplated for carrying out the present invention. However, various modifications, equivalents, variations, and alternatives will remain apparent to a person skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present invention.

[0035] For the purposes of the description below, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal" and their derivatives shall be associated with the present invention as it is oriented in the drawings. However, it is to be understood that unless explicitly stated to the contrary, the present invention may assume various alternative variations. It is also to be understood that the specific devices illustrated in the drawings and described in the following specification are merely exemplary embodiments of the present invention. Accordingly, the specific dimensions and other physical characteristics associated with the embodiments disclosed herein should not be considered limiting.

[0036] It should be understood that any numerical range recited herein is intended to include all values and sub-ranges subsumed therein. For example, a range of "1 to 10" is intended to include all sub-ranges (and including) between the recited minimum value of 1 and the recited maximum value of 10, i.e., having a minimum value equal to or greater than 1 and a maximum value equal to or less than 10.

[0037] The present disclosure relates to a disinfection device including a container containing a chlorhexidine-based solution, the chlorhexidine-based solution comprising a chlorhexidine concentration of 0.2 - 2.0% weight / volume.

[0038] Reference Figures 1-3 , the disinfection device 10 can include a container 12. The container 12 can contain a chlorhexidine-based (CH-based) solution 14 (disinfection solution). The CH-based solution can be an aqueous solution (e.g., comprising water).

[0039] The CH-based solution 14 can contain CH. The CH can have a concentration of 0.2 - 2.0% weight / volume, such as 0.4 - 1.5% weight / volume or 0.5 - 1.0% weight / volume. A concentration of CH within these ranges can provide a persistent disinfection effect, while the concentration is low enough to be safely used on patients (e.g., into a patient's bloodstream) and does not interfere with the engagement between the disinfection device 10 and a connector 18 engaged therewith. Since CH has a higher molecular weight and a lower evaporation rate than other solvents suitable for use in the disinfection device 10 such as isopropyl alcohol (IPA), a persistent disinfection effect can be achieved.

[0040] The CH in the CH-based solution 14 can include chlorhexidine acetate (CHA), chlorhexidine gluconate (CHG), chlorhexidine hydrochloride, or some combination thereof.

[0041] The CH-based solution 14 can be an aqueous solution of CH. The CH-based solution 14 can additionally contain a disinfectant as a solvent of the CH-based solution 14. The disinfectant solvent in the CH-based solution 14 can contain IPA, an aqueous solution of povidone iodine, or any other suitable disinfectant. The CH-based solution 14 can contain a disinfectant solvent (e.g., IPA) concentration of at least 25% weight / volume or at least 50% weight / volume or at least 70% weight / volume. The presence of the aqueous solvent and / or the disinfectant solvent in the CH-based solution 14 can contribute to forming a uniform CH layer on the surface of the connector 18, resulting in a persistent disinfected surface.

[0042] To confirm that the presence of CH (in combination with IPA) in the disinfection solution does not affect the antimicrobial performance of the disinfection device compared to a disinfection device containing only IPA, studies were conducted with two challenge microorganisms (one Gram-positive bacterium and one Gram-negative bacterium) and two CH variants (CHA and CHG) at concentrations in the range of 0.1% to 2.0%. As can be seen from Table 1 below, the presence of CH does not negatively affect the antimicrobial performance of the disinfection device.

[0043] Table 1

[0044]

[0045] The persistent disinfection performance of a CH-based solution 14 for caps used in IV catheters was tested. Non-limiting examples of CH-based solution 14 were prepared using a 70% IPA and 0.5% CHG (weight / volume %) solution and a 0.5% CHG aqueous solution (weight / volume %), and were used to treat caps of IV catheters. These CH-based solutions were compared to caps of untreated IV catheters or caps of IV catheters treated with 70% IPA (weight / volume %). The disinfection results of the caps using various solutions are shown in Table 2 below.

[0046] Table 2

[0047]

[0048] The results in Table 2 show that due to the fast evaporation of IPA, no persistent disinfection performance was observed with only the IPA solution. For the 0.5% CHG aqueous solution, an average of 0.5 log 10 CFU was observed. Mixing 0.5% CHG with 70% IPA resulted in an average reduction of approximately 1.5 log 10 CFU. The improved log 10 CFU reduction in the solutions containing CHG indicates improved persistent disinfection, which can be attributed to the formation of a CHG coating on the surface of the IV connector.

[0049] The CH-based solution 14 can additionally contain oil. Non-limiting embodiments of oils that can be suitable for use in the CH-based solution 14 include oils of plant origin, such as cottonseed oil, eucalyptus oil, grape seed oil, melaleuca oil, or some combination thereof. The oil can assist in the separation between the disinfection device 10 and the connector 18 by reducing the removal force that separates the components.

[0050] Reference Figure 2 and 3 , the disinfection device 10 can include a disinfection cap 16 or a disinfection washing device 20.

[0051] Figure 2Shows a non - limiting example of a disinfection device 10 in the form of a disinfection cap 16. The disinfection cap 16 can engage with a connector 18 and can act as a cap over the open end of the connector 18. The disinfection cap 16 can engage with the connector 18 in any suitable manner. For example, the disinfection cap 16 can be screwed onto the connector 18, and the connector 18 can be disinfected by immersing it in a CH - based solution 14 contained in a container 12 of the disinfection cap 16. A non - limiting example that can be modified to accommodate the CH - based solution 14 and act as a suitable cap for the disinfection device 10 / disinfection cap 16 is the BD PureHub, which can be modified to accommodate the CH - based solution 14 described herein.

[0052] Figure 3 Shows a non - limiting example of a disinfection device 10 in the form of a disinfection washing device 20. The connector 18 can be immersed in a CH - based solution 14 contained in a container 12 of the disinfection washing device 20 to disinfect the connector 18.

[0053] The disinfection device 10 can be additionally sterilized. The disinfection device 10 can be sterilized using steam sterilization. The disinfection device 10 can be sterilized using an autoclave. The disinfection device 10 can be sterilized using radiation sterilization, such as using electron beam, X - ray, and / or gamma radiation sterilization. The dose range of gamma radiation and electron beam radiation applied to the disinfection device 10 can be in the range of 10 - 90 kGy, such as 12 - 80 kGy or 15 - 60 kGy. The disinfection device 10 can be sterilized to kill any microorganisms that the CH - based solution 14 is less effective against.

[0054] Continuing to refer Figure 2 and 3 and, the disinfection device 10 can be configured to engage with a connector 18, such as a medical connector (e.g., an intravenous catheter connector). The connector 18 can include a needleless connector, a male connector, and / or a stopcock. Non - limiting, commercial examples of connectors that the disinfection device 10 can be configured to engage are the BD SmartSite and Q - Syte needleless connectors. However, it will be appreciated that the design of the disinfection device 10 can be adapted to engage any type of connector used in the medical field, which is typically disinfected before use on a patient.

[0055] Continuing to refer Figure 2 and Figure 3, the present disclosure also relates to a sterilized medical connector. The sterilized medical connector may include a connector 18 sterilized with the sterilization device 10 described herein. The connector 18 can be sterilized to form a sterilized medical connector by engaging the connector 18 with a sterilization cap 16 containing a CH-based solution 14 described herein. The connector 18 can be sterilized to form a sterilized medical connector by immersing the connector 18 in a washing device 20 containing a CH-based solution 14 described herein.

[0056] The present disclosure also relates to a method of sterilizing a medical connector 18. The connector 18 can be sterilized by contacting the connector 18 in a CH-based solution 14 of the sterilization device 10, and the CH-based solution 14 contains a chlorhexidine concentration of 0.2-2.0% weight / volume contained in a container 12 of the sterilization device 10. The CH-based solution 14 may contain an IPA concentration of at least 25% weight / volume or at least 50% weight / volume or at least 70% weight / volume. The method may include sterilizing the sterilization device 10 using steam sterilization, an autoclave, and / or radiation sterilization. Immersing the connector 18 in the CH-based solution 14 may include engaging the connector 18 with the sterilization cap 16. Immersing the connector 18 in the CH-based solution 14 may include immersing the connector 18 in a CH-based solution 14 contained in a container 12 of a sterilization washing device 20.

[0057] The connector 18 can be immersed in the CH-based solution 14 for at least 5 seconds, such as at least 8 seconds, or at least 10 seconds, to sufficiently sterilize the connector 18.

[0058] Although, for purposes of illustration, the present disclosure has been described in detail based on currently considered the most practical and preferred embodiments, it is to be understood that such details are for that purpose only and the present disclosure is not limited to the disclosed embodiments, but on the contrary, is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it is to be understood that the present disclosure contemplates, to the extent possible, combining one or more features of any embodiment with one or more features of any other embodiment.

Claims

1. A disinfection device, the disinfection device comprising a container containing a chlorhexidine-based solution, the solution comprising a chlorhexidine concentration of 0.2 - 2.0% weight / volume.

2. The disinfection device according to claim 1, wherein the chlorhexidine concentration is 0.4 - 1.5% weight / volume or 0.5 - 1.0% weight / volume.

3. The disinfection device according to claim 1, wherein the chlorhexidine-based solution comprises chlorhexidine acetate and / or chlorhexidine gluconate.

4. The disinfection device according to claim 1, wherein the chlorhexidine-based solution comprises isopropyl alcohol.

5. The disinfection device according to claim 4, wherein the chlorhexidine-based solution comprises an isopropyl alcohol concentration of at least 25% weight / volume or at least 50% weight / volume.

6. The disinfection device according to claim 1, wherein the disinfection device comprises a disinfection cap or a disinfection washing device.

7. The disinfection device according to claim 1, wherein the disinfection device is configured to engage with a medical connector.

8. The disinfection device according to claim 7, wherein the medical connector comprises a needleless connector, a male connector, and / or a stopcock.

9. The disinfection device according to claim 1, wherein the disinfection device is sterilized.

10. The disinfection device according to claim 9, wherein the disinfection device is sterilized using steam sterilization, an autoclave, and / or radiation sterilization.

11. A disinfected medical connector, comprising: A medical connector disinfected with the disinfection device of claim 1.

12. The disinfected medical connector according to claim 11, wherein the disinfection device comprises a disinfection cap that engages with the medical connector.

13. The disinfected medical connector according to claim 11, wherein the disinfection device comprises a washing device containing the chlorhexidine-based solution, and the medical connector is immersed in the solution.

14. A method for disinfecting a medical connector, comprising contacting the medical connector in a chlorhexidine-based solution containing a chlorhexidine concentration of 0.2 - 2.0% weight / volume and contained in a container of a disinfection device.

15. The method according to claim 14, wherein the chlorhexidine-based solution comprises an isopropyl alcohol concentration of at least 25% weight / volume or at least 50% weight / volume.

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