High viscosity antibacterials

• US 20060024372A1
• Filed: 08/01/2005
• Published: 02/02/2006
• Est. Priority Date: 07/29/2004
• Status: Abandoned Application

• Current Assignee: DSU Medical Corporation
• Original Assignee: DSU Medical Corporation
• Inventors: Utterberg, David S., Swindler, Fred G.
• Application Number:
  US11/194,818
• Publication Number:
  US 20060024372A1
• Time in Patent Office: Days
• US Class Current: 424/488
• CPC Class Codes: A61K 31/045 Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
• CPC Class Codes: A61K 47/10 Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
• CPC Class Codes: A61K 47/34 Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers A61K47/10 takes precedence
• 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: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00

Abstract

An antibacterial fluid may be applied to a tubular medical cannula for access to a patient. The fluid comprises a typically metabolizable antibacterial formulation having a viscosity preferably greater than 150,000 cp. The cannula may then be inserted into the patient with an increased lubricity for a reduction of pain, while at the same time, unlike silicones, preferred materials do not readily accumulate in the patient. The fluid may be placed on the skin. The tubular medical cannula may be a rigid, hollow needle, sharp or blunt, a spike, or a flexible catheter. Also, the viscous antibacterial fluid may be used to lock a catheter or other cannula while implanted in the patient, for storage purposes. The formulation is typically an alcohol plus a viscosity increasing agent and optionally a surfactant, a clotting agent, and/or EDTA.

Claims

1. A transparent, antibacterial formulation which comprises an alcohol mixed with sufficient viscosity increasing agent to provide a viscosity of more than 150,000 up to about to 500,000 cp, to the formulation, and further comprising an alcohol-soluble surfactant that improves transparency.

2. The formulation of claim 1 in which said alcohol comprises isopropanol.

3. The formulation of claim 1 which said surfactant comprises a polyoxyalkylene surfactant.

4. The formulation of claim 1 in which said viscosity of the formulation is from 170,000 to 250,000 cp.

5. The formulation of claim 1 in which said viscosity increasing agent comprises crosslinked polyvinylpyrrolidone.

6. The formulation of claim 5 which has a viscosity of about 180,000-220,000 cp.

7. The formulation of claim 1 in which said viscosity increasing agent comprises polyvinylpyrrolidone crosslinked with polyethyleneimine.

8. A cannula, carried by a hub and having a surface at least partially coated with the formulation of claim 1.

9. The method which comprises placing a fluid on the outer surface of a medical cannula, said fluid comprising an alcohol and having a viscosity of more than 150,000 cp, up to about 500,000 cp, and thereafter inserting the cannula through the skin of the patient or into a sterile receptacle.

10. The method which comprises placing a portion of a transparent fluid, which comprises an alcohol and has a viscosity of more than 150,000 cp, up to about 500,000 cp, on the skin of a patient to form a fluid layer on the skin, and thereafter passing a medical cannula through the fluid layer on the skin and through the skin of the patient.

11. The method of claim 10 in which said transparent fluid further contains an alcohol-soluble surfactant that improves transparency.

12. The method of claim 10 in which the fluid includes a viscosity increasing agent which comprises crosslinked polyvinylpyrrolidone.

13. A transparent fluid which comprises an alcohol and a surfactant, mixed with sufficient viscosity increasing agent to provide a viscosity of more than 150,000 cp, up to about 500,000 cp, said fluid having the characteristic of forming a skin on its surface when exposed to the air, to retard the evaporation of said alcohol, and thus to prolong its antibacterial effect when placed in contact with the skin or other surface.

14. The formulation of claim 13 in which said viscosity increasing agent comprises polyvinylpyrrolidone crosslinked with polyethyleneimine.

15. The formulation of claim 13 which has a viscosity of essentially 180,000 to 220,000 cp.

16. The formulation of claim 13 in which said surfactant comprises a polyoxyalkylene surfactant.

17. A medical cannula which extends through the skin of a patient and which connects to a medical flow conduit at an end of said cannula which is outside of the skin, said medical cannula extending through a pool of antimicrobial formulation carried on the skin of the patient, said pool comprising an alcohol mixed with sufficient viscosity increasing agent to provide a viscosity of more than 150,000 cp, up to about 500,000 cp, portions of said medical cannula being coated with said antimicrobial formulation.

18. The cannula of claim 17 in which said alcohol is isopropanol.

19. The cannula of claim 18 in which said viscosity increasing agent is polyvinylpyrrolidone crosslinked with polyethyleneimine.

20. The cannula of claim 17 in which said pool of antimicrobial formulation also serves as a removable adhesive to help retain said cannula in position.

21. The method which comprises:

placing on a body surface of a patient an antimicrobial formulation which consists essentially of an alcohol mixed with sufficient viscosity increasing agent to provide a viscosity of more than 150,000 cp, up to about 500,000 cp to the formulation, whereby said formulation exhibits improved physical stability over lower molecular weight counterparts.

22. The method of claim 21 in which the viscosity of the formulation is at least about 180,000 cp.

25. The method of claim 21 in which said antimicrobial formulation is placed on a patient'"'"'s body surface that is infected with a microorganism.

23. The method of claim 23 in which the alcohol comprises isopropanol.

24. The method of claim 23 in which the viscosity increasing agent comprises crosslinked polyvinylpyrrolidone.

26. An antibacterial formulation having a viscosity of greater than 150,000 cp, which comprises:

65-80 wt. percent of an alcohol;

6-10 wt. percent of polyvinylprrolidone;

from 0.2-2 wt. percent of polyethyleneimine, from 0.1-1 wt. percent of a polyalkyleneoxide surfactant, and water to make up a 100 percent balance.

27. The antibacterial formulation of claim 26 which further comprises 2-6 wt. percent propylene glycol and from 2-6 wt. percent of polyethylene glycol.

28. The formulation of claim 26 which is substantially transparent.

29. The formulation of claim 26 which includes a clotting agent in an effective concentration.

30. A formulation for use as a catheter locking formulation, having a viscosity of essentially 50,000-150,000 cp. which comprises an alcohol-water mixture that contains a viscosity increasing agent and sufficient EDTA to provide antibacterial characteristics.

31. The formulation of claim 30 in which said viscosity is no more than 100,000 cp.