HK1196297A - Antimicrobial composition including a residual barrier film - Google Patents

Description

Antimicrobial compositions comprising residual barrier films

Cross Reference to Related Applications

This application claims priority from U.S. provisional patent application 61/564,206 entitled "medical devices and techniques for antibacterial, immunomodulatory, and antitumor therapy" filed on 28/11/2011, which is hereby incorporated by reference in its entirety.

Background

Currently, infection remains a practical problem for the medical industry. Typically, infection is caused by contamination of Intravascular (IV) lines (e.g., intravenous, intra-arterial, etc.), contamination of injection or blood draw sites (e.g., from veins, arteries, or capillaries), urinary catheters, wound sites, incision sites, and many other sources of infection in medical equipment. For example, in hospitals in the united states alone, central venous catheters cause an estimated 250,000 bloodstream infections each year, which results in a significant cost of consumed financial resources and patient morbidity. O' Grady MD et al, Guidelines for the prevention of Intravascular Catheter-Related Infections, 2011, department of health and public service disease control center. These numbers do not include infections caused by contamination of the injection site, blood draw site, non-venous catheter, or any of the other numerous sources of contamination in the medical device. Infection is a more serious problem in developing countries where syringes, IV lines and other equipment are routinely used and reused for a number of different patients.

Drawings

The detailed description is set forth with reference to the accompanying drawings. In the drawings, the left-most digit(s) of a reference number identifies the figure number in which the reference number first appears. The use of the same reference numbers in different figures indicates similar or identical items or features.

Fig. 1 illustrates an exemplary port cleaning system that may include a cleaning cap having an applicator material carrying an antimicrobial composition.

Fig. 2A-2C illustrate an exemplary port cleaning and disinfecting system in which an antimicrobial composition may provide a visual indication of contamination.

Fig. 3A-3C illustrate an exemplary protective cap in which an antimicrobial composition may provide a visual indication of contamination.

Fig. 4 illustrates a nasal decolonizer device that can be used to deliver an antimicrobial composition.

Detailed Description

SUMMARY

Methods of reducing and/or preventing infection are described. In one aspect, the present application describes exemplary antimicrobial compositions that may be used alone or in combination with one or more medical devices to clean and/or disinfect Intravascular (IV) line ports, other IV components (e.g., syringes, lumens, valves, etc.), injection sites, blood draw sites (e.g., from veins, arteries, or capillaries), catheters and/or catheter insertion sites, injury sites, incision sites, peritoneal dialysis sites, bladder or nephrostomy sites, other drainage sites, or any other site susceptible to infection.

Exemplary antimicrobial compositions

In an exemplary implementation, antimicrobial compositions that may be used in connection with the methods described herein may include, for example, 9/1/2010Those described in filed U.S. patent applications 12/874, 188 (in the name of Tennican et al), which are incorporated herein by reference. In this case, the antibiotic component may include water (H)₂O), concentrated non-toxic chelating agents (e.g., ethylenediaminetetraacetic acid EDTA (e.g., disodium EDTA, disodium calcium EDTA, magnesium EDTA, gallium EDTA) or sodium citrate (or acids, salts, derivatives or other forms of EDTA or sodium citrate)), short chain monohydric alcohols (e.g., having formula C)₂H₅OH and empirical formula C₂H₆Ethanol of O), and concentrated small molecule oxidants (e.g., hydrogen peroxide (H)₂O₂)). In one particular example, the composition may consist essentially of water, EDTA, ethanol, and hydrogen peroxide. However, in other embodiments, other antimicrobial compositions may be used in conjunction with the devices described herein.

The antimicrobial component may be, for example, in liquid form or in gel form or foam form, depending on the needs of a particular application, and may be combined with one or more carriers or diluents. For example, in applications where the antimicrobial composition is used as a hand sanitizer, the antimicrobial composition may be in the form of a gel. As another example, if the antimicrobial composition is used as a cleaning agent, a rinse solution, or a stimulant, the antimicrobial composition may be in liquid form. In such a case, the concentration of the various components (e.g., the desired level of disinfection) may depend on whether the composition is applied directly to living tissue or a medical device, and/or whether irritation to tissue to which the composition is applied directly or indirectly (e.g., by the medical device to which the composition is applied or has been applied) is avoided. In another example, the antimicrobial composition in liquid form may be evaporated or sprayed for application to the nasal passages or other airways of a patient. In yet another example, the antimicrobial composition may include or be combined with a lubricant (e.g., glycerin), surfactant or emulsifier (e.g., Glycerol Monolaurate (GML)), or the like, and be applied to a catheter, endotracheal tube, scope, instrument, or other device that is inserted into the patient's body.

Exemplary film or Barrier layer

In addition to providing disinfection at the time of application, the antimicrobial composition may also provide a durable barrier against contamination. For example, even after volatile components in the composition (e.g., water, alcohol, hydrogen peroxide, etc.) have volatilized, the chelating agent remains on the surface being treated (e.g., the port cleaning/protection device, the finger, surrounding tissue, etc.) as a barrier that provides antimicrobial, antifungal or sporicidal (e.g., preventing spore germination), antiparasitic, and antiviral properties. By depriving the environment of elements (e.g., iron, magnesium, and manganese) necessary for bacterial, spore, parasitic, and viral regeneration, chelating agents provide a long-lasting defense against contamination even after other components of the antimicrobial composition have volatilized. Moreover, the hydrogen peroxide in the antimicrobial composition may induce a charge (charge) on the surface of the material (e.g., silicon material) to which the antimicrobial composition is applied, which makes the material more resistant to bacteria and other microorganisms.

Fig. 1 shows an exemplary IV port cleaning system 100, the IV port cleaning system 100 including a cleaning cap 102 having an applicator material 104 carrying an antimicrobial composition (such as those described above). The cleaning cap 102 may be used to clean the IV port 106. In the example shown, the IV port includes a female shapeA connecting member. However, in other embodiments, such an IV port cleaning system may be used or adapted for use on a male partOrConnections, and other types of IV and non-IV ports and/or lumens. The cleaning cap 102 may be used, for example, to sterilize the IV port 106 prior to connecting the port to a complementary port, prior to injecting medication, prior to drawing blood, or prior to using the IV port 106. After being sterilized, the volatile components of the antimicrobial composition volatilize over time, leaving behindA film or barrier layer 108 of EDTA or other chelating agents (as described above) that provides a durable defense against contamination.

Once sterilized, a protective cap (not shown in this figure) may be applied to the IV port 106 to provide a physical barrier against recontamination. The protective cap may contain the same or different antimicrobial or other components. In some implementations, the protective cap may be securely coupled with the IV port 106 and may seal the IV port. If the antimicrobial components in the protective cap dry out over time, the protective cap still includes a residual barrier layer of EDTA or other chelating agents that provide further protection against contamination. In other embodiments, instead of one of the antimicrobial components described above, the protective cap may simply be coated on all or part of its inner and/or outer surface with a film or barrier layer of EDTA or other chelating agent.

Although FIG. 1 illustrates one embodiment of an IV port cleaning system including a cleaning cap 102, in other embodiments, other cleaning devices may be used to carry and apply the antimicrobial composition in accordance with the present disclosure. By way of example, and not limitation, other cleaning devices may be used, including a pad, a cotton swab, a wet wipe, a sponge, or any other material capable of carrying an antimicrobial composition. Further, while fig. 1 illustrates that the antimicrobial composition and cap system may be used to clean an IV port, antimicrobial compositions and cleaning devices according to the present disclosure may also clean and/or disinfect other IV components, injection sites, blood draw sites, catheter and/or catheter insertion sites, wound sites, incision sites, peritoneal dialysis sites, drainage sites, or any other site susceptible to infection.

Moreover, in addition to their cleaning, disinfecting and barrier properties, the antimicrobial compositions described above may include one or more therapeutic uses, such as those described below and those described in international patent application PCT/US2011/022150 (in the name of Tennican et al), filed on 21/1/2011, which is incorporated herein by reference.

Exemplary contamination indicator

In addition to their cleaning, disinfecting, barrier properties, and therapeutic uses, the antimicrobial compositions described above provide a visual indicator of contamination that allows the healthcare provider to identify and clean or replace contaminated equipment to prevent infection. Details of the function of such indicators will be described below with reference to the exemplary IV port cap systems of fig. 2A-2C and 3A-3C. However, the indicator function of the antimicrobial composition is not limited to such a system and is applicable regardless of the system or process in which the antimicrobial composition is used.

Fig. 2A-2C illustrate the IV port cleaning and sterilizing system 100 of fig. 1 in detail. In particular, FIG. 2A shows the cleaning cap 102 prior to use. As shown in fig. 2A, the cleaning cap 102 can be used with a protective cap 200, the protective cap 200 maintaining the interior of the cleaning cap 102 in a sterile condition. Additionally or alternatively, the cleaning cap 102 may be enclosed within another sterile package (not shown in this figure) to maintain the entire cleaning cap 102 in a sterile condition prior to use. To clean the IV port 106 with the cleaning cap 102, the protective seal may be removed, thereby exposing the interior of the cap 102, as shown in fig. 2B. The cleaning cap 102 is then placed over the IV port 106 and twisted, or the IV port 106 is wiped and cleaned with the cleaning cap 102. Specifically, the applicator material 104 carrying the antimicrobial composition may be used to wipe the exterior surface of the IV port 106 by twisting and pressing the cleaning cap 102 against the IV port 106.

If the IV port 106 becomes contaminated with bacteria, spores, parasites, viruses, bodily fluids, or other contaminants, the antimicrobial composition will begin to foam or froth 202, thereby providing a visual indicator of contamination. The foaming or frothing action is caused by the reaction of hydrogen peroxide with bacteria, spores, parasites and viruses. Specifically, the enzymes that are contaminants that foam hydrogen peroxide in the antimicrobial composition include, but are not limited to, catalase, superoxide dismutase (SOD), glutathione peroxidase, and other oxidases, and the like. Oropharyngeal, respiratory, cervicovaginal secretions and sera also contain hydrogen peroxide reactants or enzymes that foam the antimicrobial components. EDTA somewhat attenuated these reactions. However, tests have shown that this reduction is slight and does not impair the ability of the antimicrobial composition to visually indicate the presence of contamination. For example, according to the present application, staphylococcus aureus (MRSA) with catalase and pseudomonas aeruginosa with SOD both produced abundant foam when contacted with antibacterial ingredients. Hydrogen peroxide also generates bubbles or foam in response to Fenton's reaction with iron from hemoglobin in red blood cells, or peroxidase in white blood cells and body fluids. The size and rate of bubble formation can indicate the level of contamination, giving medical personnel a visual indication of the instrument being contaminated and the relative degree to which the instrument is contaminated (e.g., more or larger bubbles/foam indicates more contamination). Based on the indication, the medical personnel may decide that the instrument needs further cleaning and/or replacement to avoid infection.

Fig. 3A-3C illustrate an exemplary protective cap 300, which protective cap 300 may be used in some embodiments in conjunction with the cleaning cap 102 of fig. 1 and 2A-2C. After the IV port 106 is cleaned, the protective cap 302 may be removed from the protective cap 300, thereby exposing the interior of the protective cap, as collectively shown in fig. 3A and 3B. Just as with the cleaning cap 102, the protective cap 300 may be enclosed within another sterile package (not shown in this figure) such that the entire protective cap 300 is sterile prior to use.

The protective cap 300 may then be applied to the IV port 106 to provide a physical barrier against recontamination, as shown in fig. 3C. The protective cap 300 may contain the same or different antimicrobial or other components than the cleaning cap 102. When the protective cap 300 is coupled to the IV port 106, if a foaming or frothing 304 phenomenon occurs, the foaming or frothing will provide a visual indicator to the medical personnel that the IV port 106 is still contaminated and needs further cleaning and/or replacement.

In some embodiments, the antimicrobial composition in the cleaning cap 102, the protective cap 300, or both, may contain a dye or colorant that serves as a visual indication of further enhanced contamination. If provided, the dye or colorant in the cleaning cap 102 may be the same or a different color than in the protective cap 300. For example, the color of the dye or colorant may match the color of the respective cap. In another example, the color of the dye or colorant may contrast with the color of the respective cap.

Exemplary nasal/oropharyngeal device

Fig. 4 illustrates a nasal decolonizer device 400, which device 400 may be used to deliver antimicrobial compositions, such as those described herein, to the nasal passages of a patient. The antimicrobial composition of this embodiment may contain concentrations of alcohol and hydrogen peroxide that are lower than those used in port and site cleaning and disinfecting applications due to the more sensitive nature of the nasal passages. The nasal decolonizer device 400 can apply an antimicrobial composition to the area of the nasal and oropharyngeal passageways of MRSA, or other resistant bacteria, carriers (and/or prior to an optional surgical implant). The antimicrobial composition may be dispensed as a spray or gel.

As shown in FIG. 4, the nasal decolonizer device 400 includes a reservoir 402 for containing an antimicrobial composition and a dispensing orifice 404, the dispensing orifice 404 being sized and shaped to at least partially fit into the nasal passages of a patient. The dispensing spout 404 may be made of a relatively soft, pliable material, and in some implementations, the dispensing spout 404 may act as an applicator or spreader of gel or liquid to enter the interior surface of the nose and/or nasal passages. Prior to use, the dispensing spout 404 is covered by a frangible tab 406 that hermetically seals the nasal decolonizer device 400.

Nasal decolonizers 400 or other medical devices of varying sizes, shapes, materials, and configurations (having dispensing spouts for sprays or gels contained in reservoirs) may be used to deliver antibacterial, immunomodulatory and/or oncology therapies to sites within the body or sites that are difficult to reach.

Conclusion

Although the present application describes embodiments with specific structural features and/or method steps, it is to be understood that the claims are not necessarily limited to the specific features or method steps described. Rather, the specific features and method steps are merely illustrative of some of the embodiments that fall within the scope of the claims of the present application.

Claims (20)

1. A method, comprising:

identifying a surface to be decontaminated;

applying a medical applicator to the surface, wherein the medical applicator comprises:

a cap device comprising a cylindrical cavity having a foam-like insert; or a nasal decolonizer device comprising a reservoir; and

an antimicrobial composition within the foam insert of the cap device or the reservoir of the nasal decolonizer device, wherein the antimicrobial composition comprises water, alcohol, a peroxide or peroxide generating agent, and a chelating agent; and

receiving an indication that the antimicrobial composition is in contact with one or more contaminants on the surface.

2. The method of claim 1, wherein the one or more contaminants comprise at least one of one or more bacteria, spores, parasites, viruses, bodily fluids, or combinations thereof.

3. The method of claim 2, wherein the one or more contaminants comprise staphylococcus aureus (MRSA), pseudomonas aeruginosa or other resistant bacteria.

4. The method of claim 1, wherein the antimicrobial composition further comprises:

ethylenediaminetetraacetic acid (EDTA) at about 5mg/ml to about 50 mg/ml;

up to about 70% by volume of ethanol;

up to about 7.5% by volume of hydrogen peroxide; and

and (3) water.

5. The method of claim 1, wherein the antimicrobial composition is in the form of a liquid or gel.

6. The method of claim 1, wherein the amount of chelating agent is such that water, alcohol and peroxide remain on the surface after dissipation.

7. The method of claim 1, wherein receiving an indication that the antimicrobial composition is in contact with one or more contaminants on the surface comprises foaming or frothing.

8. The method of claim 1, wherein the surface to be decontaminated comprises human tissue or an area on a medical device.

9. A method of providing a barrier against contamination comprising;

identifying a surface to be protected;

applying an antimicrobial agent to the surface, wherein the antimicrobial agent comprises water, a low molecular weight alcohol, a peroxide or peroxide generating agent, and a chelating agent;

wherein the amount of chelating agent is such that water, low molecular weight alcohol, peroxide or peroxide generator remains on the surface after evaporation.

10. The method of claim 9, wherein the surface to be protected comprises human tissue or an area on a medical device.

11. The method of claim 9, wherein the antimicrobial agent further comprises:

ethylenediaminetetraacetic acid (EDTA) at about 5mg/ml to about 50 mg/ml;

up to about 70% by volume of ethanol;

up to about 7.5% by volume of hydrogen peroxide; and

and (3) water.

12. The method of claim 9, wherein the antimicrobial agent is in the form of a liquid or gel.

13. The method of claim 9, wherein the chelating agent remains on the surface inhibiting the ability of bacteria, spores, fungi, parasites, and viruses to multiply.

14. A method of visually indicating one or more contaminants on a surface, comprising:

determining one or more surfaces to be decontaminated;

applying an antimicrobial agent to the surface, wherein the antimicrobial agent comprises water, a low molecular weight alcohol, a peroxide or peroxide generating agent, and a chelating agent; and

receiving an indication that the antimicrobial agent is in contact with one or more contaminants on the surface.

15. The method of claim 14, wherein the surface to be decontaminated comprises human tissue or an area on a medical device.

16. The method of claim 14, wherein the antimicrobial agent further comprises:

ethylenediaminetetraacetic acid (EDTA) at about 5mg/ml to about 50 mg/ml;

up to about 70% by volume of ethanol;

up to about 7.5% by volume of hydrogen peroxide; and

and (3) water.

17. The method of claim 14, wherein receiving an indication that the antimicrobial agent is in contact with one or more contaminants on the surface comprises a visual indication, such as foaming or frothing, on the surface.

18. The method of claim 14, wherein the one or more contaminants comprise at least one of one or more bacteria, one or more spores, one or more parasites, one or more viruses, one or more bodily fluids.

19. The method of claim 18, wherein the one or more contaminants comprise staphylococcus aureus (MRSA), pseudomonas aeruginosa or other resistant bacteria.

20. The method of claim 14, wherein the amount of chelating agent in the antimicrobial agent does not inhibit an indication that the antimicrobial agent is in contact with one or more contaminants on the surface.