PRESURGICAL TREATMENT METHODS AND SYSTEMS

• US 20150273198A1
• Filed: 06/12/2015
• Published: 10/01/2015
• Est. Priority Date: 09/12/2008
• Status: Abandoned Application

• Current Assignee: Sonescence, Inc.
• Original Assignee: Sonescence, Inc.
• Inventors: Silberg, Barry Neil
• Application Number:
  US14/738,606
• Publication Number:
  US 20150273198A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/3211 Surgical scalpels, knives; Accessories therefor
• CPC Class Codes: A61B 2017/00889 antimicrobial, disinfectant
• CPC Class Codes: A61K 31/546 containing further heterocyclic rings, e.g. cephalothin
• CPC Class Codes: A61K 38/14 Peptides containing saccharide radicals; Derivatives thereof , e.g. bleomycin, phleomycin, muramylpeptides or vancomycin
• CPC Class Codes: A61M 37/0092 using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis
• CPC Class Codes: A61N 2007/0004 Applications of ultrasound therapy
• CPC Class Codes: A61N 2007/0017 Wound healing
• CPC Class Codes: A61N 7/00 Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092

Abstract

Antibiotics are administered in a surgical site subcutaneously via a small or stab incision in the surgical field. Transcutaneous ultrasonic vibrations are applied across the surgical field, which is then opened in the usual manner, to thereby provide a surgical field which contains a vastly higher and more effective level of antibiotic. At the same time the underlying tissue is hydrated.

Claims

1. A method of reducing an incidence of infection in a patient at a surgical site associated with a surgical procedure, the method comprising:

identifying a region of tissue of the patient that will be exposed during the surgical procedure;

subcutaneously introducing a solution comprising a dose of a drug dissolved therein through a skin of the patient at a location to or in a vicinity of the identified region of tissue;

applying ultrasound transcutaneously toward the identified region of tissue and the subcutaneously introduced solution, wherein the transcutaneously applied ultrasound interacts with the solution to disperse the solution with the dose of drug dissolved therein through the identified region of tissue;

exposing the identified region of tissue to air; and

performing the surgical procedure.

2. The method of claim 1, further comprising making a stab wound in the skin at the location prior to subcutaneously introducing the solution to or in a vicinity of the identified region of tissue.

3. The method of claim 2, wherein the solution is subcutaneously introduced using an irrigating needle having a blunt tip that is inserted into the patient through the stab wound in the skin at the location.

4. The method of claim 2, wherein the stab wound is 1 cm or less in depth.

5. The method of claim 2, wherein exposing the identified region of tissue to air comprises performing a surgical incision along the skin of the patient.

6. The method of claim 5, wherein the stab wound is along the surgical incision path.

7. The method of claim 1, wherein at least 250 cc of solution is subcutaneously introduced through the skin of the patient.

8. The method of claim 1, wherein the antibiotic comprises a β

-lactam antibiotic.

9. The method of claim 8, wherein the antibiotic comprises a penicillin or a cephalosporin.

10. The method of claim 1, wherein the ultrasound is transcutaneously applied for 5 minutes or less at a power density of 2.5 to 4 W/cm2 and at a frequency less than 5 MHz.

11. A method of open surgery, the method comprising:

identifying a tissue site of the patient that will be exposed during the open surgery;

preparing a tissue site for the open surgery by;

subcutaneously introducing a solution comprising a dose of an antibiotic dissolved therein through a skin of the patient at a location to or in a vicinity of the identified tissue site;

applying ultrasound transcutaneously toward the identified tissue site and the subcutaneously introduced solution, wherein the transcutaneously applied ultrasound interacts with the solution to disperse the solution with the dose of antibiotic dissolved therein through the identified region of tissue, the dose of antibiotic dissolved in the solution being dispersed through the infected tissue at therapeutically effective concentrations for reducing an incidence of infection at the identified region of tissue during the open surgery.

12. The method of claim 11, wherein the antibiotic comprises a β

-lactam antibiotic.

13. The method of claim 12, wherein the antibiotic comprises a penicillin or a cephalosporin.

14. The method of claim 11, wherein the ultrasound is transcutaneously applied for 5 minutes or less at a power density of 2.5 to 4 W/cm2 and at a frequency less than 5 MHz.

15. The method of claim 11, wherein the concentration of the antibiotic in the tissue is therapeutically effective for reducing the incidence of infection while the maintaining of a serum concentration to less than 10 micrograms/ml one hour after the application of transcutaneous ultrasound, wherein maintaining the serum concentration to less than 10 micrograms/ml one hour after the application of transcutaneous ultrasound reduces adverse side effects to bacterial flora in a gastrointestinal tract of the patient.

16. The method of claim 11, wherein side effects associated with systemic application of the antibiotic are avoided.

17. A system for preparing a tissue site of a patient for an open surgery procedure, the system comprising:

a cannula for subcutaneously injecting a solution with a dose of an antibiotic dissolved therein to a tissue site of the patient that will be exposed to air during the open surgery;

an ultrasound system configured to broadcast ultrasound transcutaneously toward the identified tissue and the subcutaneously injected solution, wherein the ultrasound system is configured to broadcast ultrasound at a power density of 2.5 to 4 W/cm2 and at a frequency of less than 5 MHz that is configured to interact with the subcutaneously injected solution to disperse the subcutaneously injected solution with the dose of antibiotic dissolved therein through the tissue at a concentration; and

wherein the concentration of antibiotic in the identified tissue is therapeutically effective for reducing an incidence of infection at the identified tissue during the open surgery.

18. The system of claim 17, further comprising the solution with the dose of antibiotic, wherein the dose of the antibiotic dissolved therein is less than a dose of the antibiotic required for intravenous injection or for oral administration.

19. The system of claim 17, further comprising 250 cc of the solution with the antibiotic dissolved therein.

20. The system of claim 17, wherein the concentration of antibiotic in the tissue is therapeutically effective for reducing an incidence of infection at the identified tissue during the open surgery while maintaining serum concentration of the antibiotic to less than 10 micrograms/ml one hour after the application of the transcutaneous ultrasound.

21. The system of claim 17, wherein the ultrasound system is configured to broadcast ultrasound transcutaneously toward the identified tissue for five minutes or less.

22. The system of claim 17, further comprising a temperature monitor for preventing inadvertent heat damage to a skin of the patient during the broadcast of transcutaneous ultrasound.

23. The system of claim 17, wherein the solution is dispersed by microstreaming.

24. The system of claim 17, wherein the solution is dispersed by cavitation.

25. The system of claim 17, wherein the broadcasted ultrasound disperses the dose of antibiotic through the tissue at a concentration of at least 200 micrograms/ml fifty minutes after the broadcast of transcutaneous ultrasound.