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Medical devices having antimicrobial coatings thereon

a technology of antimicrobial coating and medical devices, which is applied in the direction of instruments, prostheses, catheters, etc., can solve the problems of hindering the use of antimicrobial coatings containing leachable antimicrobial agents, affecting the ocular health of the eye in which the lens is located, and affecting the use of antimicrobial coatings. to achieve the effect of low cytotoxicity and high antimicrobial efficacy

Inactive Publication Date: 2005-01-13
NOVARTIS AG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

is to provide an antimicrobial coating which has a hig

Problems solved by technology

Contact lenses are often exposed to one or more microorganisms during wear, storage and handling.
Microbial adherence to and colonization of contact lenses may enable microorganisms to proliferate and to be retained at the ocular surface for prolonged periods and thereby may cause infection or other deleterious effects on the ocular health of the eye in which the lens is used.
There are some disadvantages associated with this approach for making antimicrobial contact lenses.
Polymeric composition's having antimicrobial properties may not possess all properties desired for contact lenses, especially extended-wear contact lenses, which hinders their practice uses.
Antimicrobial coatings containing leachable antimicrobial agents may not be able to provide antimicrobial activity over the period of time when used in the area of the human body.
However, antimicrobial compounds in such coatings may exhibit diminished activity when comparing the activity of the unbound corresponding antimicrobial compounds in solution, unless assisted by hydrolytic breakdown of either the bound antimicrobial compounds or the coating itself.
Like the above-described approach, the antimicrobial coating may not be able to provide desired surface properties such as hydrophilicity and / or lubricity and also may have adverse effects on the desired bulk properties of a medical device (for example, the oxygen permeability of a contact lens).
However, such antimicrobial coatings have disadvantages and are unsatisfactory.
The overuse of antibiotics can lead to proliferation of antibiotic-resistant microorganisms.
Other coatings may not have broad spectrum antimicrobial activity, may produce ocular toxicity or allergic reactions, or may adversely affect lens properties required for ensuring corneal health and for providing the patient with good vision and comfort.
Moreover, surgical and device related infection remains to be one of the main clinical and economic challenges in the field of medical devices and in health care industry in general.

Method used

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  • Medical devices having antimicrobial coatings thereon
  • Medical devices having antimicrobial coatings thereon
  • Medical devices having antimicrobial coatings thereon

Examples

Experimental program
Comparison scheme
Effect test

example 1

Contact Angle

The contact angle generally measures the surface hydrophilicity of a medical device, e.g., a contact lens. In particular, a low contact angle corresponds to more hydrophilic surface. Average contact angles (Sessile Drop) of contact lenses are measured using a VCA 2500 XE contact angle measurement device from AST, Inc., located in Boston, Mass.

Antimicrobial Activity Assay

Antimicrobial activity of a contact lens with or without a silver-containing antimicrobial LbL coating of the invention is assayed against Pseudomonas aeruginosa GSU # 3, which is isolated from a corneal ulcer. Bacterial cells of Pseudomonas aeruginosa GSU # 3 stored in a lyophilized state. Bacteria are grown on an tryptic soy agar slant for 18 hours at 37° C. The cells are harvested by centrifugation and washed twice with sterile, Delbeco's phosphate buffered saline. Bacterial cells are suspended in PBS and adjusted to Optical Density of 108 cfu. The cell suspension is serially diluted to 103 cfu...

example 2

Polyacrylic acid (PAA) solution: A solution of polyacrylic acid having a molecular weight of about 2,000, from PolyScience, is prepared by dissolving a suitable amount of the material in water to form a 4% PAA solution.

Poly(diallyldimethylammonium chloride) (PDDA) solution: A solution of PDDA having a molecular weight of about 400,000 to 500,00 from Aldrich, is prepared by dissolving a suitable amount of the material in water to form a 0.5% PDDA solution. The pH is adjusted by adding 0.1M NaOH solution until the pH is about 8.0.

A coating having multiple bilayers of PDDA / Ag—NP is formed on a glass slide. The glass slide is dipped in the PDDA solution for 10 min. The glass slide with a first layer of PDDA is then dipped in the PAA solution for 10 minutes. Then the glass slide is dipped again in PDDA for 10 min and then dipped in the Ag—NP solution for 10 minutes. Finally, the steps of dipping in the PDDA solution for 10 minutes followed by dipping in the Ag—NP solution for 10 min...

example 3

Polyacrylic acid (PAA) solution: A solution of polyacrylic acid having a molecular weight of about 90,000, from PolyScience, is prepared by dissolving a suitable amount of the material in water to form a 0.001M PM solution. The PM concentration is calculated based on the repeating unit in PM. Once dissolved, the pH of the polyanionic PM solution is adjusted by adding 1N hydrochloric acid until the pH is about 2.5.

Poly(diallyldimethylammonium chloride) (PDDA) solution: PDDA is a polyquat. A solution of PDDA having a molecular weight of about 400,000 to 500,00 from Aldrich, is prepared by dissolving a suitable amount of the material in water to form a 0.5% PDDA solution. The pH is adjusted by adding 0.1M NaOH solution until the pH is about 8.0.

A coating having multiple bilayers of PDDA / Ag—NP is formed on a soft contact lens made of a fluorosiloxane hydrogel material, lotrafilcon A (CIBA Vision). The contact lens is dipped in the PM solution (0.001M, pH 2.5) for 30 minutes to form...

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Abstract

The present invention provides a medical device, preferably a contact lens, which a core material and an antimicrobial metal-containing LbL coating that is not covalently attached to the medical device and can impart to the medical device an increased hydrophilicity. The antimicrobial metal-containing coating on a contact lens of the invention has a high antimicrobial efficacy against microorganisms including Gram-positive and Gram-negative bacterial and a low toxicity, while maintaining the desired bulk properties such as oxygen permeability and ion permeability of lens material. Such lenses are useful as extended-wear contact lenses. In addition, the invention provides a method for making a medical device, preferably a contact lens, having an antimicrobial metal-containing LbL coating thereon.

Description

The present invention generally relates to a medical device having an antimicrobial metal-containing layer-by-layer coating thereon and to a method for making the medical device of the invention. BACKGROUND Contact lenses are often exposed to one or more microorganisms during wear, storage and handling. They can provide surfaces onto which the microorganisms can adhere and then proliferate to form a colony. Microbial adherence to and colonization of contact lenses may enable microorganisms to proliferate and to be retained at the ocular surface for prolonged periods and thereby may cause infection or other deleterious effects on the ocular health of the eye in which the lens is used. Therefore, it is desirous to make various efforts to minimize and / or eliminate the potential for microorganism adhesion to and colonization of contact lenses. Many attempts have been made to develop antimicrobial medical devices. Two approaches have been proposed. One approach is to incorporate antim...

Claims

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Application Information

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IPC IPC(8): A61L27/34A61L27/54A61L29/10A61L29/16A61L31/08A61L31/10G02B1/04
CPCA61L27/34A61K31/14A61L29/106A61L29/16A61L31/088A61L31/10A61L31/16A61L2300/104A61L2300/404A61L2300/45A61L2300/608A61L2300/61A61L2300/624G02B1/043A61K9/5015A61L27/54Y10T428/31678Y10T428/31692Y10T428/31681A61P31/04
Inventor QIU, YONGXINGWINTERTON, LYNN COOKLALLY, JOHN MARTINKOTOV, NICHOLAS
Owner NOVARTIS AG
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