Antimicrobial alcohol gel pre-operative skin-preparation delivery system

• US 6,488,665 B1
• Filed: 06/11/1998
• Issued: 12/03/2002
• Est. Priority Date: 04/08/1997
• Status: Expired due to Fees

• Current Assignee: Allegiance Corporation (Cardinal Health, Inc.), Aplicare, Inc. (Clorox Company)
• Original Assignee: Allegiance Corporation (Cardinal Health, Inc.)
• Inventors: Wilson, Bruce H., Jeng, David K., Childers, David A., Severin, Jane E.
• Primary Examiner(s): Coggins, Wynn Wood
• Assistant Examiner(s): MAYNARD, JENNIFER J
• Application Number:
  US09/096,256
• Time in Patent Office: 1,636 Days
• Field of Search: 604/19, 604/200, 604/310, 604/289, 604/309, 141/110, D 4/137, D 4/199, 15/34, D24/114, 427/429, 222/212, 222/215, 239/327, 401/132-135, 401/205-207
• US Class Current: 604/200
• CPC Class Codes: A01N 2300/00 Combinations or mixtures of active ingredients covered by classes A01N27/00 - A01N65/48 with other active or formulation relevant ingredients, e.g. specific carrier materials or surfactants, covered by classes A01N25/00 - A01N65/48
• CPC Class Codes: A01N 25/04 Dispersions, emulsions, suspoemulsions, suspension concentrates or gels foams A01N25/16
• CPC Class Codes: A01N 25/24 containing ingredients to enhance the sticking of the active ingredients
• CPC Class Codes: A01N 25/34 Shaped forms, e.g. sheets, not provided for in any other sub-group of this main group
• CPC Class Codes: A01N 31/02 Acyclic compounds
• CPC Class Codes: A01N 59/12 Iodine, e.g. iodophors; Compounds thereof
• CPC Class Codes: A61K 31/79 Polymers of vinyl pyrrolidone
• CPC Class Codes: A61K 47/38 Cellulose; Derivatives thereof
• CPC Class Codes: A61K 9/0014 Skin, i.e. galenical aspects of topical compositions non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00
• CPC Class Codes: A61P 31/02 Local antiseptics

Abstract

The present invention provides antimicrobial skin-preparation delivery systems useable to disinfect a surgical site for surgery. The delivery systems include an antimicrobial alcohol gel formulation contained within a sealed, flexible container and a gel formulation dispenser connected to the container. The gel formulation dispenser includes a container connector connected to the flexible container and a gel applicator having a sealed piercing member which is slidably engaged with the container connector. An applicator pad is porous and also has enlarged holes for passage of the gel formulation. The gel formulation dispenser pierces a seal in the container and delivers the antimicrobial alcohol gel formulation from the container to the surgical site. Flow rate of the gel formulation is largely controlled by the amount of external pressure of squeezing a user applied to the flexible container. The antimicrobial skin-preparation formula includes iodine, alcohol and gel.

Claims

1. An antimicrobial gel skin preparation delivery device comprising:

a flexible container having a top opening and including an antimicrobial gel skin preparation composition disposed in the flexible container and a rupturable seal sealing the top opening;

a container connector including a first end releasably connected to the flexible container about the top opening and an elongated hollow tube having an internal passageway extending from the first end to an opposed second end with an opening;

an applicator member including an elongate hollow shaft with a longitudinal bore having a central longitudinal axis, the shaft having a first end with a seal piercing point and at least one opening communicating with the bore and having a second end with a head flange projecting perpendicularly outwardly from the shaft defining an applicator head surface with a central opening communicating with the bore, the applicator head surface being disposed at an angled orientation with respect to the central longitudinal axis;

a sponge applicator having a plurality of gel release holes secured to the applicator head surface so that the gel release holes are disposed adjacent the central opening;

the applicator being engaged with the container connector so that the shaft is telescopically received within the internal passageway; and

the container connector and applicator member including cooperatively engageable structural features permitting the applicator member to be moved from an engaged closed position wherein the shaft is received in the internal passageway with the seal piercing point spaced from the rupturable seal and a gel dispensing position

wherein the shaft is advanced within the passageway so that the rupturable seal is ruptured by the seal piercing point and antimicrobial gel may flow from the container through the shaft to the sponge applicator, and so that in the gel dispensing position, the applicator member is maintained at a constant rotational position relative to the container connector;

and wherein said antimicrobial gel skin preparation composition comprises alcohol from about 60.0% v/v to about 90.0% v/v of the formulation;

iodine from about 1.0% w/v to about 15.0% w/v of the formulation; and

gel from about 0.1% w/v to about 20.0% w/v of the formulation.

2. An antimicrobial gel skin preparation delivery device as defined in claim 1, wherein the top opening of the container includes an external threaded section and the first end of the container connector includes internal threads threadedly engaging the external threads.

3. The antimicrobial gel skin-preparation delivery device of claims 1, wherein the applicator member comprises an outer tubular section which defines a channel between the outer tubular section and the elongated tube of the container connector is slideably received in the channel.

4. The antimicrobial gel skin-preparation delivery device of claim 1, wherein the applicator member includes a pair of opposed slide channels and the container connector includes a pair of opposed wings slidably received in the slide channels.

5. The antimicrobial skin-preparation delivery device of claim 1, wherein the alcohol is selected from the group consisting of ethyl alcohol, methyl alcohol, isopropyl alcohol, butyl alcohol and propyl alcohol.

6. The antimicrobial skin-preparation delivery device of claim 1, wherein the iodine is povidone iodine.

7. The antimicrobial skin-preparation delivery device of claim 1, wherein the gel is a water soluble gel.

8. The antimicrobial skin-preparation delivery device of claim 1, wherein the gel comprises:

simethicone from about 0.1% w/v to about 20% w/v of the formulation; and

hydroxypropylcellulose from about 0.1% w/v to about 30% w/v of the formulation.

9. The antimicrobial skin-preparation delivery device of claim 1, wherein the antimicrobial gel skin preparation composition further comprises a base pH adjuster from about 0.01% w/v to about 2% w/v of the formulation.

10. The antimicrobial skin-preparation delivery device of claim 9, therein the base pH adjuster is an alkali earth metal hydroxide.

11. The antimicrobial skin-preparation delivery device of claim 1, wherein the antimicrobial gel skin preparation composition further comprises an acid pH adjuster from about 0.01% w/v to about 5% w/v of the formulation.

12. The antimicrobial skin-preparation delivery device of claim 1, wherein the antimicrobial gel skin preparation composition further comprises a skin irritation reducer from about 0.1% w/v to about 5% w/v of the formulation.

13. The antimicrobial skin-preparation delivery device of claim 1, wherein the skin irritation reducer is selected from the group consisting of glycerin, petroleum jelly, petrolatum, mineral oil, ethylene glycol and glycerol.

14. The antimicrobial skin-preparation delivery device of claim 1, wherein the antimicrobial gel skin preparation composition comprises:

ethyl alcohol at about 62.0% v/v of the formulation;

povidone iodine at about 5.0% w/v of the formulation; and

gel at about 7.5% w/v of the formulation.

15. The antimicrobial skin-preparation delivery device of claim 14, wherein the antimicrobial gel skin preparation composition further comprises:

sodium hydroxide at about 0.2% w/v of the formulation;

citric acid at about 0.5% w/v of the formulation; and

glycerin at about 1.0% w/v of the formulation.