IP Library Granted Patent US 12,357,594
Granted Patent B1
US 12,357,594 · App. 17/853,389 · Granted Jul 15, 2025

Antimicrobial solution for pre-operative preparation

Inventors: Jodi M. Balbinot (Cary, IL); Jennifer M. Allen (Cary, IL)
Assignee: Sage Products, LLC
A61K31/155A61K9/0014A61K9/08A61K31/045A61K47/26A61P31/02
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Quick Facts
Patent No.
US 12,357,594
App. No.
17/853,389
Granted
Jul 15, 2025
Kind
B1
Abstract

A method for the preparation of a patient's skin prior to surgery includes applying a volume of an antiseptic solution to the skin surface prior to surgery in an amount effective to reduce bacteria on the skin surface; and allowing the antiseptic solution to stand on the skin surface for less than three minutes before commencing surgery. The antiseptic solution includes a biguanide and benzyl alcohol, and is comparable to an antiseptic solution containing at least 60% isopropyl alcohol or at least 60% ethyl alcohol at reducing bacteria.

Claims (28)

1. A method for the preparation of a patient's skin prior to surgery, comprising:

applying a volume of a non-flammable antiseptic solution to the skin surface prior to surgery in an amount effective at reducing bacteria on the skin surface; and

allowing the non-flammable antiseptic solution to stand on the skin surface for about 1 second to about three minutes before commencing surgery,

wherein the non-flammable antiseptic solution comprises about 0.5% wt to about 4.0% wt of chlorhexidine gluconate and about 0.5% wt to about 3% wt of benzyl alcohol, and is at least as effective at reducing bacteria as a flammable antiseptic solution comprising 70% wt of isopropyl alcohol or 70% wt of isopropyl alcohol and 2% wt of chlorhexidine gluconate, and

wherein the volume of the non-flammable antiseptic solution is dependent on the surface area to be prepared.

2. The method of claim 1 , wherein the non-flammable antiseptic solution comprises 2% wt of the benzyl alcohol 2% wt of the chlorhexidine gluconate.

3. The method of claim 2 , wherein the non-flammable antiseptic solution consists essentially of the 2% wt of chlorhexidine gluconate, the 2% wt of benzyl alcohol, and 96% wt of water.

4. The method of claim 1 , wherein the non-flammable antiseptic solution further comprises a surfactant.

5. The method of claim 4 , wherein the surfactant is lauryl glucoside.

6. The method of claim 1 , wherein commencing surgery comprises activating a surgical tool comprising a potential fire ignition source.

7. The method of claim 6 , wherein the potential fire ignition source is one or more selected from electrosurgical equipment, electrocautery equipment, and a laser.

8. The method of claim 1 , wherein commencing surgery comprises draping the patient.

9. The method of claim 1 , wherein the volume of the non-flammable antiseptic solution applied to the skin surface is greater than or equal to 3 mL.

10. The method of claim 9 , wherein the volume of the non-flammable antiseptic solution applied to the skin surface is selected from 3 mL, 10 mL, and 26 mL.

11. The method of claim 1 , wherein the bacteria has the potential to cause a skin infection.

12. The method of claim 1 , wherein the non-flammable antiseptic solution achieves a log reduction of bacteria that is greater than or equal to X−0.5 log 10 , wherein X is the log reduction achieved by the flammable antiseptic solution comprising 70% wt of isopropyl alcohol or 70% wt of isopropyl alcohol and 2% wt of chlorhexidine gluconate.

13. The method of claim 1 , wherein the bacteria is gram positive.

14. The method of claim 1 , wherein the bacteria is selected from one or more of Enterococcus faecalis, Enterococcus faecium, Staphylococcus aureus, Burkholderia cepacian, Acinetobacter baumannii, Bacteroides fragilis, Proteus mirabilis, Serratia marcescens , or Staphylococcus haemolyticus.

15. The method of claim 1 , wherein the bacteria is gram negative.

16. A method for the preparation of a patient's skin prior to surgery, comprising:

applying a volume of a non-flammable antiseptic solution to the skin surface prior to surgery in an amount effective at reducing bacteria on the skin surface;

wherein the non-flammable antiseptic solution comprises about 0.5% wt to about 4.0% wt of chlorhexidine gluconate and about 0.5% wt to about 3% wt of benzyl alcohol, and achieves a log reduction of bacteria that is greater than or equal to X−0.5 log 10 ,

wherein X is the log reduction achieved by a flammable antiseptic solution comprising 70% wt of isopropyl alcohol or 70% wt of isopropyl alcohol and 2% wt of chlorhexidine gluconate, and

wherein the volume of the non-flammable antiseptic solution is dependent on the surface area to be prepared.

17. The method of claim 16 , wherein the non-flammable antiseptic solution comprises 2% wt of the benzyl alcohol and 2% wt of the chlorhexidine gluconate.

18. The method of claim 16 , wherein the volume of the non-flammable antiseptic solution applied to the skin surface is greater than or equal to 3 mL.

19. The method of claim 16 , further comprising allowing the non-flammable antiseptic solution to dry for less than three minutes before activating a potential fire ignition source.

20. The method of claim 19 , wherein the potential fire ignition source is one or more selected from electrosurgical equipment, electrocautery equipment, and a laser.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 2, 2022
From: BALBINOT, JODI M.; ALLEN, JENNIFER M.
To: SAGE PRODUCTS, LLC
Reel/Frame 060691/0518 →
Continuity (1)
Provisional Application 63217023 · Jun 30, 2021
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