TUMESCENT ANTIBIOTIC SOLUTION

• US 20120322783A1
• Filed: 11/30/2010
• Published: 12/20/2012
• Est. Priority Date: 11/30/2009
• Status: Active Grant

• Current Assignee: HK Tumescent Pharma
• Original Assignee: Jeffrey Alan Klein
• Inventors: Klein, Jeffrey Alan
• Granted Patent: US 8,957,060 B2
• Time in Patent Office: Days
• US Class Current: 514/206
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/137 Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
• CPC Class Codes: A61K 31/167 having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
• CPC Class Codes: A61K 31/546 containing further heterocyclic rings, e.g. cephalothin
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• 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
• CPC Class Codes: A61K 9/0021 Intradermal administration, e.g. through microneedle arrays, needleless injectors mechanical aspects A61M
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 5/14 Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
• CPC Class Codes: A61P 31/00 Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: A61P 7/02 Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors

Abstract

Disclosed herein are solutions and kits for tumescent antibiotic delivery. Embodiments of the solution comprise an antibiotic component, an anesthetic component and a vasoconstrictor component. In addition, a method of use is disclosed comprising subcutaneous delivery of the solution. The disclosed solution, kit and method of subcutaneous delivery can be used for a variety of surgical procedures including liposuction, mastectomy and others. The tumescent antibiotic solution can be administered to a patient in situations where establishing IV access is difficult, impossible, or undesirable. A variety of delivery methods appropriate for surgical settings, as well as for use by first responders are likewise disclosed.

Claims

1. A method for reducing surgical site infection in a patient during a medical procedure, comprising administering subcutaneously a tumescent antibiotic composition, compromising:

(a) an antibiotic component;

(b) an anesthetic component;

(c) a vasoconstrictor component; and

(d) a pharmaceutically acceptable carrier.

2. The method of claim 1, wherein the anesthetic component comprises lidocaine.

3. The method of claim 2, wherein the concentration of lidocaine IS approximately 500 mg to 1,000 mg per L of solution

4. The method of claim 1, wherein the vasoconstrictor component comprises epinephrine.

5. The method of claim 4, wherein the concentration of epinephrine is approximately 0.5 to 1 mg per L.

6. The method of claim 1, wherein the antibiotic component comprises cefazolin.

7. The method of claim 1, wherein the antibiotic component comprises a mixture of two or more antibiotics.

8. The method of claim 1, wherein the composition further comprises an anti-inflammatory agent.

9. The method of claim 1, wherein the medical procedure is liposuction.

10. The method of claim 1, wherein the medical procedure comprises removal of subcutaneous tissue from the patient.

11. The method of claim 1, wherein the medical procedure is a mastectomy.

12. A method of preventing thromboembolism in a patient during a medical procedure, comprising administering into the subcutaneous fat compartment of the patient a composition comprising an antibiotic component, a vasoconstrictor component and an anesthetic component, in a pharmaceutically acceptable carrier.

13. A tumescent antibiotic composition, comprising:

(a) an antibiotic component;

(b) an anesthetic component;

(c) a vasoconstrictor component; and

(d) a pharmaceutically acceptable solvent.

14. The composition of claim 13, wherein the antibiotic component comprises cefazolin at a concentration of between 250 to 1000 mg per liter of solvent.

15. The composition of claim 13, wherein the antibiotic component comprises a mixture of two or more antibiotics.

16. The composition of claim 13, wherein the anesthetic component comprises lidocaine at a concentration of between 400 to 1200 mg per liter of solvent.

17. The composition of claim 13, wherein the vasoconstrictor component comprises epinephrine at a concentration of 0.4 to 1.2 mg per liter of solvent.

18. The composition of claim 13, wherein the composition has an acidic pH.

19. The composition of claim 13, wherein the vasoconstrictor component comprises a mixture of epinephrine and one or more vasoconstrictors other than epinephrine.

20. The composition of claim 13, further comprising an anti-inflammatory agent.

21. A kit for tumescent antibiotic delivery, comprising a bag prefilled with the composition of claim 13 and a tumescent infiltration cannula.

22. The kit of claim 21, wherein the bag is visually distinguishable from IV bags.

23. A method of providing antibiotic treatment to an acute infection, comprising administering into the subcutaneous fat compartment a solution comprising an antibiotic component and a vasoconstrictor component.

24. The method of claim 23, wherein the antibiotic component comprises cefazolin.

25. The method of claim 23, wherein the solution further comprises an anesthetic component.

26. The method of claim 23, wherein the vasoconstrictor component comprises epinephrine.

27. The method of claim 23, wherein the solution further comprises an anti-inflammatory agent.