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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 intraocular lens, packaging goods type, peptide/protein ingredients, etc., can solve the problems of affecting the use of the eye, affecting the ocular health of the eye in which the lens is located, and not possessing all the properties desired for polymeric compositions having antimicrobial properties, etc., to achieve low cytotoxicity and high antimicrobial

Inactive Publication Date: 2008-10-23
NOVARTIS AG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The antimicrobial coating effectively inhibits microbial growth on contact lenses while ensuring low cytotoxicity and maintaining the lens's bulk properties, such as oxygen permeability and comfort, making it suitable for extended-wear applications.

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.
First, polymeric compositions having antimicrobial properties may not possess all properties desired for contact lenses, especially extended-wear contact lenses, which hinders their practice uses.
Second, antimicrobial compounds may exhibit greatly diminished activity since they may not in contact with microorganisms adhered to the surface of contact lens.
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 greatly 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.
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.

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
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Effect test

example 1

Preparation of Coating Solutions

Polyacrylic Acid (PAA) Solution

[0095]A solution of polyacrylic acid (PAA) having an averaged molecular weight of about 90,000 is prepared by dissolving a suitable amount of PAA in water to have [PAA]=0.001 M. PAA concentration is calculated based on the repeating unit in PAA. Once dissolved, the pH of the PAA solution is adjusted to a desired value.

Poly(allylamine hydrochloride) (PAH) Solution

[0096]A solution of poly(allylamine hydrochloride) (PAH) having an averaged molecular weight of about 60,000 is prepared by dissolving a suitable amount of the material in water to form a 0.001 M PAH solution. PAH concentration is calculated based on the repeating unit in PAH. Once dissolved, the pH of the PAH solution is adjusted to a desired value.

Polyquat (PQ) Solutions

[0097]A solution of polyquat (PQ6-6) of formula (I), in which R1, R2, R3, and R4 are methyl groups, and A and B are hexamethylene groups, is prepared by dissolving a suitable amount of PQ6-6 in ...

example 2

Preparation of Contact Lenses Having LbL Coatings

[0102]This example illustrates LbL coatings and several types of antimicrobial coatings which are formed on soft contact lenses made of a fluorosiloxane hydrogel material, lotrafilcon A.

(1) Coating comprising four and half bilayers:

[0103]PAA / PAH / PAA / PAH / PAA / PAH / PAA / PAH / PAA

[0104]The contact lenses are dipped in a PAA solution (0.001 M, pH2.5) for 30 min, rinsed with ultra-pure water, then dipped in a PAH solution (0.001 M, pH7.5) for 5 minutes, rinsed with ultra-pure water for 1 minute. Three more bilayers are added by alternatively dipping in the solutions of PAA (0.001 M, pH 3.5) and PAH (0.002M, pH 7.5), with a rinse step in-between. The contact lenses with four bilayers of polyelectrolytes is dipped in the PAA solution (0.001 M, pH 3.5) and rinsed with ultra-pure water for 1 minute. The lenses are then packaged in saline and sterilized.

(2) Antimicrobial Coating comprising 6 Bilayers:

[0105]PAA / PAH / PAA / PAH / PAA / PAH / PAA / PAH / PA / PAH / PAA / ...

example 3

[0118]This example illustrates how to produce a covalently-attached antimicrobial coating on a contact lens made of lotrafilcon A, lotrafilcon B, or Balafilcon.

[0119]The contact lens is functionalized by spraying with or dipped into a diaziridine compound and then covalently coupling the diaziridine compound to the contact lens via a thermal process. Such functionalised lens is placed in an open dish containing a polyquat (PQ6-6, PQ6-10, PQ6-12, or PDADMAC) solution of about 10 μg / ml and irradiated with blue light for 30 minutes.

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PUM

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Abstract

The present invention provides a medical device, preferably a contact lens, which comprises an antimicrobial coating including at least one layer of polyquat of formula (I) or (II). The antimicrobial coating on the medical device of the invention has a high antimicrobial efficacy against microorganisms including Gram-positive and Gram-negative bacterial, a low toxicity, low coefficient of friction, and increased hydrophilicity 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 coating thereon.

Description

[0001]This application claims the benefit under 35 U.S.C. §119(e) of United state provisional application Ser. No. 60 / 332,289 filed Nov. 14, 2001.[0002]The present invention generally relates to a medical device having an antimicrobial coating thereon. In particular, the present invention relates to an ophthalmic lens having an antimicrobial coating that has antimicrobial efficacy and low cytotoxicity as well as other desired properties such as low coefficient of friction, hydrophilicity, and high oxygen permeability and ion permeability. In addition, this invention provides a method for making a medical device having an antimicrobial coating.BACKGROUND[0003]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 o...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A01N25/34A01N33/12A61K38/40G01N19/02G02C7/04A61F2/16A61F9/00A61K31/785A61K45/00A61L27/00A61L27/34A61L31/10A61L33/16A61P31/00G02B1/04
CPCA61L27/34G02B1/043A61L31/10A61P31/00
Inventor MORRIS, CAROL ANNGABRIEL, MANAL M.QIU, YONGXINGWINTERTON, LYNN COOKLALLY, JOHN MARTINASH, MARCIA KAYCARNEY, FIONA PATRICIAMORGAN, COURTNEY FLEM
Owner NOVARTIS AG
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