Antimicrobial compositions

a technology of compositions and antimicrobials, applied in the field of antimicrobial compositions, can solve the problems of disseminated bsi (blood stream infection), affecting the effect of infection, etc., to achieve the effect of easy application, good adhesion, and easy application

Inactive Publication Date: 2010-06-03
BECTON DICKINSON & CO
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0014]The present invention has been developed in response to problems and needs in the art that have not yet been fully resolved by currently available antimicrobial compositions and methods. Thus, these compositions and methods are developed to reduce complications, such as the risk and occurrence of CRBSIs, by providing improved antimicrobial compositions and methods for use in conjunction with medical devices.
[0022]In certain embodiments, a rheological modifier can preferrably be added to the composition. The rheological modifier allows the flow characteristics of the composition to be controlled and modified as desired. The rheological modifier can also aid in the uniform distribution of antimicrobial agent and other materials within the composition. Suitable rheological modifiers may include organic clay, castor wax, polyamide wax, polyurethane, and fumed silica or combinations of these materials.
[0024]In another aspect, the invention may be solventless. As mentioned above, many conventional coatings employ harsh solvents such as THF and DMF. The present invention is operable without the use of solvents and, therefore, avoids the difficulties presented by the use of conventional solvents.
[0025]The formulations also demonstrate good adhesion to numerous plastic surfaces (such as PC, PU, PVC, acrylics, and SBR). The formulation can be cured with adequate ultraviolet light (wavelength of approximately 200 nm to 600 nm, and in certain embodiments in the range of from about 300 nm to about 450 nm).
[0026]Accordingly, the present invention provides antimicrobial coating compositions which overcome many of the limitations of existing technology. The present invention employs known components which have achieved acceptance for medical use. These components are combined and used easily and efficiently. As set forth above, the compositions of the present invention generally including oligomers, monomers, photoinitiators, rheological modifiers, and suitable antimicrobial agents. The resulting compositions are easily applied to the surfaces of medical devices and quickly cured by UV light.

Problems solved by technology

One of the major challenges of modern medical treatment is control of infection and the spread of microbial organisms.
When the septum of a vascular access device fails to operate properly or has inadequate design features, certain complications may occur.
Complications associated with infusion therapy may cause significant morbidity and even mortality.
A vascular access device may serve as a nidus of infection, resulting in a disseminated BSI (blood stream infection).
This may be caused by failure to regularly flush the device, a non-sterile insertion technique, or by pathogens that enter the fluid flow path through either end of the path subsequent to catheter insertion.
When a vascular access device is contaminated, pathogens adhere to the vascular access device, colonize, and form a biofilm.
Because THF can be oxidized very quickly and tends to be very explosive, an expensive explosion-proof coating facility is necessary.
Therefore, medical devices made with these materials can become distorted over time and / or form microcracks on their surfaces.
Another issue with this type of coating is that it takes almost 24 hours for the solvent to be completely heat evaporated.
Accordingly, conventional technology has persistent problems with processing, performance, and cost.
Another limitation is the availability of suitable antimicrobial agents for use in such coatings.
These technologies are tedious, expensive, and not environmentally friendly.
In addition, the performance of silver coated medical devices is mediocre at best.
As a result, substantial microbial activity can occur prior to the silver coating even becoming effective.
Furthermore, the silver compound or silver element has an unpleasant color, from dark amber to black.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0037]UV-curable compositions within the scope of the present invention were formulated and their microbial kill rate and zone of inhibition were tested as set forth in Table 1 below. Each of the compositions was essentially identical except for the antimicrobial agent which was varied as set forth below. The composition was comprised of a UV curable composition designated EMI 7104. The UV curable composition was comprised of 30-70% oligomer, 20-60% monomer; 2-7% photoinitiator. Added to 100 parts of the UV curable composition was 2.6 parts fumed silica obtained from Cabot and designated Cabot's MS-55. Also added was 7.2 parts antimicrobial agent. The specific antimicrobial agent was used in the formulation were as follows:[0038]Samples #1. Chlorhexidine diacetate[0039]2. Alexidine[0040]3. Silver sulfadiazine[0041]4. Silver acetate[0042]5. Silver citrate hydrate[0043]6. Cetrimide[0044]7. Cetyl pyridium chloride[0045]8. Benzalknonium chloride[0046]9. o-phthalaldehyde[0047]10. Silver ...

example 2

[0050]In these examples several antimicrobial agents were incorporated into UV curable coating compositions within the scope of the present invention. Each of the formulations included 100 parts of 7104 UV coating, 2.6 parts of fumed silica [designed M-5], and 5.0 parts of antimicrobial agent. Silver and chlorhexidine were included in the test because they are commonly used antimicrobial agents being used in medical technologies. The results of these tests are set forth in Table 2.

TABLE 2Contact Kill and Zone of inhibition of selectiveantimicrobial agents in UV formulation (5% agents)ProductsContact Kill (%)Zone of Inhibition1 Minute (5%)S. EpiP. AeruC. AlbiS. EpiP. AeruC. AlbiChlorhexidine37.6 0.039.021.513.5 19.0DiacetateCetrimide72.296.687.830.00.023.0Cetyl Pyridium100.0 100.0 100.0 16.50.013.0ChlorideBenzalkonium15.8 0.058.523.50.023.5ChlorideSilver*2——————Chlorhexidine——————Gluconate*2

[0051]When 7 parts antimicrobial agent is used the results set forth in Table 3 were obtained....

example 3

[0052]In Table 4, the formulation set forth above was prepared using cetyl pyridium chloride (formulation #1) as the antimicrobial agent. This composition has 100% contact kill within 1 min. The same formulation using chlorhexidine diacetate (formulation #4) as the agent has 100% contact kill within 1 hour for all three types of microorganisms. However, both conventional compositions had 100% contact kill for selected microbes only after about 8 hours (both are using silver compound or silver element as the agent).

TABLE 4Commercial Formulation AnalysisContact Kill (%)Zone of Inhibition (mm)ProductsS. EpiP. AeruC. AlbiS. EpiP. AeruC. AlbiCommercial Formulation 11 min.——————1 hr.0.09.211.08 hr.10099.70.0Commercial Formulation 21 min.0.00.013.77.57.510.01 hr.0.010095.28 hr.10010089.5(PC) 11 min.10010010016.30.013.51 hr.1001001008 hr.100100100(PC) 41 min.24.637.726.321.811.517.31 hr.1001001008 hr.100100100(PC) 1: Cetyl pyridium chloride as the agent.(PC) 4: Chlorhexidine diacetate as th...

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Abstract

Antimicrobial compositions and methods are disclosed. The antimicrobial compositions are particularly useful in providing antimicrobial capability to a wide-range of medical devices. In one aspect the invention relates a UV curable antimicrobial coating comprising a UV curable composition comprising an oligomer, a momoner, and a photoinitiator which are together capable of forming a UV curable polymer composition. The compositions include rheology modifiers as necessary. The compositions also include antimicrobial agents, which may be selected from a wide array of agents. Representative antimicrobial agents include cetyl pyridium chloride, cetrimide, alexidine, chlorexidine diacetate, benzalkonium chloride, and o-phthalaldehyde.

Description

RELATED APPLICATIONS[0001]This application claims priority to U.S. provisional patent application No. 61 / 118,988, filed Dec. 1, 2008, entitled “Antimicrobial Compositions and Methods for Medical Product Use,” which application is incorporated herein by this reference.BACKGROUND OF THE INVENTION[0002]The present invention relates to antimicrobial compositions and methods for use of those compositions in various medical applications. One of the major challenges of modern medical treatment is control of infection and the spread of microbial organisms.[0003]One area where this challenge is constantly presented is in infusion therapy of various types. Infusion therapy is one of the most common health care procedures. Hospitalized, home care, and other patients receive fluids, pharmaceuticals, and blood products via a vascular access device inserted into the vascular system. Infusion therapy may be used to treat an infection, provide anesthesia or analgesia, provide nutritional support, t...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A01N25/00A01P1/00
CPCA61L29/085C10M2215/06A61L2300/206A61L2300/208A61L2300/404B05D3/0254B05D3/067C08F220/18C08F222/1006C09D4/06C09D5/14C09D5/1668C10M169/04C10N2230/16C10N2220/082C10M2229/0515C10N2240/66C10M2215/04C10M2205/14C10M2201/105A61L29/16C08F220/1808C08F222/102B05D7/04B05D7/24C10M105/20C10M105/40C10M105/58C10M125/04C10M125/06C10M125/16C10M125/20C10M125/26C10M129/24C10M133/00C10N2020/06C10N2030/16C08F220/1811C08F222/103C08F222/104C10N2040/50
Inventor OU-YANG, DAVID TIEN-TUNG
Owner BECTON DICKINSON & CO
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