Tumescent antibiotic solution

• US 9,623,030 B2
• Filed: 12/19/2014
• Issued: 04/18/2017
• Est. Priority Date: 06/25/2004
• Status: Expired due to Term

• Current Assignee: HK Pharma, Co.
• Original Assignee: Jeffrey Alan Klein
• Inventors: Klein, Jeffrey Alan
• Primary Examiner(s): Ramachandran, Uma
• Application Number:
  US14/578,147
• Publication Number:
  US 20150182536A1
• Time in Patent Office: 851 Days
• Field of Search: 514206
• 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 surgical procedure, comprising administering by tumescent delivery to a subcutaneous compartment of a surgical site in the patient a tumescent antibiotic composition, comprising:

(a) an antibiotic component;

(b) lidocaine, wherein the concentration of lidocaine is approximately 100 mg to 1,500 mg per L of solution;

(c) a vasoconstrictor component in an amount sufficient to cause intense subcutaneous vasoconstriction and to direct hydrostatic compression of capillaries and veins; and

(d) a pharmaceutically acceptable carrier,

wherein a mass of the tumescent antibiotic composition remains in the patient and is isolated from systemic circulation in the patient by virtue of capillary vasoconstriction, wherein only components of the mass of tumescent antibiotic composition that are located at the outer boundary of the mass of tumescent antibiotic composition are available for absorption, whereas the portion of the tumescent antibiotic composition located within the central portion of the mass of fluid is isolated from systemic circulation by the capillary vasoconstriction, thereby reducing risk of systemic toxicity from elevated serum levels of the antibiotic component and/or the lidocaine.

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

3. The method of claim 2, wherein the concentration of epinephrine is approximately 0.2 to 1.5 mg per L.

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

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

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

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

8. The method of claim 1, wherein the medical surgical procedure comprises an incision through the skin into the subcutaneous tissue of the patient or removal of subcutaneous tissue from the patient.

9. The method of claim 1, wherein the medical surgical procedure is selected from the group consisting of mastectomy, gastrointestinal surgery, orthopedic surgery, vascular surgery, obstetric surgery, trauma surgery, burn surgery and general surgery.

14. The method according to claim 1, wherein the surgical site is a site of a proposed surgical incision or surgical intervention.

15. The method according to claim 1, wherein the surgical site is a site of a burn requiring surgery.

16. The method according to claim 1, wherein the surgical site is a combat wound injury.

10. A method of providing antibiotic treatment to an acute infection, comprising administering into a subcutaneous fat compartment a tumescent antibiotic solution comprising:

(a) an antibiotic component;

(b) lidocaine, wherein the concentration of lidocaine is approximately 100 mg to 1,500 mg per L of solution; and

(c) a vasoconstrictor component in an amount sufficient to cause intense subcutaneous vasoconstriction and to direct hydrostatic compression of capillaries and veins

wherein a mass of the tumescent antibiotic composition remains in the patient and is isolated from systemic circulation in the patient by virtue of capillary vasoconstriction, wherein only components of the mass of tumescent antibiotic composition that are located at the outer boundary of the mass of tumescent antibiotic composition are available for absorption, whereas the portion of the tumescent antibiotic composition located within the central portion of the mass of fluid is isolated from systemic circulation by the capillary vasoconstriction, thereby reducing risk of systemic toxicity from elevated serum levels of the antibiotic component and/or the lidocaine.

11. The method of claim 10, wherein the antibiotic component comprises cefazolin.

12. The method of claim 10, wherein the vasoconstrictor component comprises epinephrine.

13. The method of claim 10, wherein the tumescent solution further comprises an anti-inflammatory agent.