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United States Patent (19) 11 Patent Number: 6,039,940 Perrault Et Al

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United States Patent (19) 11 Patent Number: 6,039,940 Perrault Et Al US0060399.40A United States Patent (19) 11 Patent Number: 6,039,940 Perrault et al. (45) Date of Patent: Mar. 21, 2000 54) INHERENTLY ANTIMICROBIAL 5,563,056 10/1996 Swan et al.. QUATERNARY AMINE HYDROGEL WOUND 5,599.321 2/1997 Conway et al.. DRESSINGS 5,624,704 4/1997 Darouiche et al.. 5,670.557 9/1997 Dietz et al.. 75 Inventors: James J. Perrault, Vista, Calif.; 5,674.561 10/1997 Dietz et al.. Cameron G. Rouns, Pocatello, Id. 5,800,685 9/1998 Perrault. FOREIGN PATENT DOCUMENTS 73 Assignee: Ballard Medical Products, Draper, Utah 92/06694 4/1992 WIPO. WO 97/14448 4/1997 WIPO. 21 Appl. No.: 09/144,727 OTHER PUBLICATIONS 22 Filed: Sep. 1, 1998 I. I. Raad, “Vascular Catheters Impregnated with Antimi crobial Agents: Present Knowledge and Future Direction,” Related U.S. Application Data Infection Control and Hospital Epidemiology, 18(4): 63 Continuation-in-part of application No. 08/738,651, Oct. 28, 227–229 (1997). 1996, Pat. No. 5,800,685. R. O. Darouiche, H. Safar, and I. I. Raad, “In Vitro Efficacy of Antimicrobial-Coated Bladder Catheters in Inhibiting 51) Int. Cl." .......................... A61K31/785; A61F 13/00 Bacterial Migration along Catheter Surface,” J. Infect. Dis., 52 U.S. Cl. ..................................... 424/78.06; 424/78.08; 176: 1109-12 (1997). 424/78.35; 424/78.37; 424/443; 424/445 W. Kohen and B. Jansen, “Polymer Materials for the Pre 58 Field of Search ..................................... 424/443, 445, vention of Catheter-related Infections.” Zbl Bakt., 283: 424/78.06, 78.07, 78.08, 78.35, 78.37 175-186 (1995). 56) References Cited Primary Examiner Robert H. Harrison U.S. PATENT DOCUMENTS Attorney, Agent, or Firm-Locke Liddell & Sapp LLP 3,898,188 8/1975 Rembaum et al.. 57 ABSTRACT 3,975,350 8/1976 Hudgin et al.. 4,119,094 10/1978 Micklus et al.. A composition and method for treating a wound with an 4,191,743 3/1980 Klemm et al.. inherently antimicrobial dressing. The dressing is a hydrogel 4.226.232 10/1980 Spence. containing from about 15 to 95 percent, and preferably from 4,318.947 3/1982 Joung. about 61 to 90 percent, by weight of a cationic quaternary 4,373,009 2/1983 Winn. amine acrylate polymer prepared by the polymerization of 4,393,048 7/1983 Mason, Jr. et al.. acryloyloxyethyl(or propyl)-trialkyl(or aryl)-substituted 4,515,593 5/1985 Norton. ammonium Salts or acrylamidoethyl(or propyl)-trialkyl(or 4,563,184 1/1986 Korol. aryl)-substituted ammonium salts. The antimicrobial hydro 4,570,629 2/1986 Widra. gels are non-irritating to the wound, absorb wound exudate, 4,657,006 4/1987 Rawlings et al.. 4,705,709 11/1987 Vailancourt. and, due to the inherently antimicrobial properties, enhance 4,728,323 3/1988 Matson. the sterile environment around the wound. The hydrogels 4,769,013 9/1988 Lorenz et al.. have Sufficient adhesive properties that loose contact with 4,791,063 12/1988 Hou et al.. the wound is assured but can also be removed without 5,004,760 4/1991 Patton et al. ......................... 424/78.27 leaving any gel residue on the wound. The wound dressings 5,006,267 4/1991 Vaughn et al. .......................... 210/755 are preferably formed on a Substrate, Such as a web or patch, 5,019,096 5/1991 Fox, Jr. et al.. for ease in application to and removal from the wound. If 5,069,907 12/1991 Mixon et al.. desired, additional antimicrobial or other pharmaceutically 5,082,697 1/1992 Patton et al. ............................ 427/340 active agents can also be incorporated into the hydrogel 5,269,770 12/1993 Conway et al. 5,432,000 7/1995 Young, Sr. et al.. Structure. 5,498,478 3/1996 Hansen et al.. 5,512,329 4/1996 Guire et al.. 15 Claims, No Drawings 6,039,940 1 2 NHERENTLY ANTIMICROBAL biopolymer polyelectrolyte component derived from either QUATERNARY AMINE HYDROGEL WOUND collagen or a glucosamineglycan. The membranes may also DRESSINGS contain antibiotics. Klemm et al., U.S. Pat. No. 4,191,743, teache the admin This application is a continuation-in-part of application istration of antibiotics to wounds using a wound dressing Ser. No. 08/738,651 filed Oct. 28, 1996 and issued Sep. 1, comprising at least two layers of Synthetic resin arranged 1998 as U.S. Pat. No. 5,800,685. one above the other having an intermediate layer composed This invention is drawn to hydrogel wound dressings that of a Synthetic resin granulate having an antibiotic incorpo are inherently antimicrobial. More particularly, this inven rated therein. tion is drawn to inherently antimicrobial hydrogels contain It is known that certain quaternary amine Salts possess ing wound dressings wherein the hydrogel is formed by the antimicrobial properties. Examples include benzethonium polymerization of acrylated quaternary ammonium mono chloride and benzalkonium chloride (Bactine(R). It is also mers in an aqueous media. known that certain quaternary amines can be incorporated In the past, wounds have been treated with antimicrobial into polymeric Substrates to provide a certain degree of active agents applied to the wound and covered with a 15 antimicrobial activity. covering that inhibits the healing process. For example, it Rebaum et al., U.S. Pat. No. 3,898,188, teach cationic was conventional practice early in the 20th Century to apply polyelectrolytes homopolymers formed from an alkyl amine an antiseptic mercury agent Such at thimerosal (Merthiolate) halide monomer that are useful for various medical appli or merbromin (Mercurochrome) and the like to a wound and cations. These polymers are formed by the head-to-tail then cover or wrap the wound with a bandage Such as gauze quaternization reaction of the monomer to form linear or an adhesive Strip having a central absorbent gauze por chains. Such polyelectrolyte homopolymers are taught to tion. possess bacteriocidal activity and can be topically applied to A disadvantage of this approach is that the wound often traumatic skin areas Such as in the treatment of burns, weeps or exudes fluids Such as blood, pustulation and the abrasions or cuts. However, the homopolymers do not like. While the gauze may absorb some of these fluids, the 25 possess gel forming capabilities and, in order to form a gauze often adheres to the wound Such that removal of the moisture retaining structure, must be combined with a dressing reopens the wound. polyvinyl alcohol or polyvinyl pyrrollidone polymer. Such Advances in the art have been made in both bandages and combinations result in films that can impregnate gauze antimicrobial agents. Certain bandages now contain a non materials to form an antiseptic or germicidal dressing mate adhering polymeric coating over or, in place of, the gauze rial. The homopolymers may also be converted to branch that inhibits the adhering of the absorbent material to the polymers having a comb-like Structure by attaching the wound but also inhibits the absorption of the exudate that is quaternary homopolymer to the backbone of a polymeric necessary to properly heal the wound. Substrate Such as a poly-dialkylaminoalkylacrylates or a Certain wound dressing materials have been used to polyalkylaminoacrylamides. Such comb-like polymers are absorb exudate and promote healing. For example, Mason, 35 useful for coating onto Substrates Such as photocopy paper. et al., U.S. Pat. No. 4,393,048 teaches a hydrogel compo Further, the polyelectrolyte monomers can be copolymer Sition which, when applied as a powder, absorbS wound ized with anionic polymerS Such as polystyrene Sulfonates, exudate. The hydrogel formation may not be complete and polyacrylates or heparin to provide copolymers that can coat lumps of partially hydrated powders form which, when Surfaces Such as tubes, catheters, valves and the like with a removed, may reopen the wound. 40 non-thrombogenic coating. It is known that wounds heal more rapidly and com Hou et al., U.S. Pat. No. 4,791,063, teach polyionene pletely if kept in a slightly moist or hydrated State. Poly transformed modified polymer-polysaccharide Separation ethylene glycol containing hydrogel wound coverings are matrices for use in removing contaminants of microorgan disclosed in Spence, U.S. Pat. No. 4,226,232. These hydro ism origin from biological liquids. This patent teaches that gels cannot be Sterilized by irradiation due to the formation 45 absorption of bacterial cells by ion-exchange resins is attrib of free radicals. utable to electrostatic attraction between quaternary ammo Rawlings et al., U.S. Pat. No. 4,657,006, illustrate wound nium groups on the resin Surface and carboxyl groups on the dressings comprised of a hydrophilic polymer having mois bacteria cell Surface. ture and vapor permeability properties. However, the eXu Hansen et al., U.S. Pat. No. 5,498,478 is directed to the date absorbed by the hydrophilic polymer tends to harden or 50 use of a polyethylene glycol or Similar polymer as a binder solidify the polymer. material for fibers of any variety. The binder and fibers may An ideal wound dressing should not only absorb exudate be pretreated by Slurrying the fibers in baths containing but also possess antimicrobial properties. For example, antimicrobial agents as part of the Solution, thereby causing Matson, U.S. Pat. No. 4,728,323 discloses a wound dressing the fibers and the Subsequently formed matrix of polymer comprising a Substrate coated with an antimicrobial coating 55 and fibers to have an antimicrobial ability. of a Silver Salt that allegedly keeps the wound moist. Mixon et al., U.S. Pat. No. 5,069,907 is directed to the Korol, U.S. Pat. No. 4,563,184, discloses wound dress formation and use of a polymeric Sheet which may include ings comprising a polymer, Such as poly (2- an antimicrobial agent.
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