Pre-Surgical Prophylactic Administration of Antibiotics and Therapeutic Agents

• US 20100069827A1
• Filed: 03/17/2009
• Published: 03/18/2010
• Est. Priority Date: 09/12/2008
• Status: Abandoned Application

• Current Assignee: Sonescence, Inc.
• Original Assignee: Sonescence, Inc.
• Inventors: Silberg, Barry Neil
• Application Number:
  US12/405,616
• Publication Number:
  US 20100069827A1
• Time in Patent Office: Days
• US Class Current: 604/22
• 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 process for protecting a surgical site from infection, the process comprising the steps of:

a) defining within a surgical or treatment field an incision line,

b) making a first small incision at or about the incision line,

c) injecting a quantity of antibiotic or other therapeutic agent subcutaneously about the incision line via the first small incision,

d) broadcasting energy transcutaneously to disperse the antibiotic agent and fluid subcutaneously,

e) making a second incision along the incision line, the first incision being a fraction of the incision line and the second incision being substantial all or the remainder of the incision line not opened by the first incision wherein the effective dose of the antibiotic or therapeutic agent in adjacent adipose tissue exceeds 250 μ

g/ml a half hour after injection while the serum concentration remains less than about 30 μ

g/ml.

2. A process for protecting a surgical site from infection according to claim 1 wherein the antibiotic is a Beta Lactam and the effective dose of the antibiotic in adjacent adipose tissue exceeds 500 μ

g/ml for up to a half hour after injection to be effective against MRSA.

3. A process for protecting a surgical site from infection according to claim 1 wherein the antibiotic is Cephazolin and the effective dose of the antibiotic exceeds 250 μ

g/ml to be effective against MRSA.

4. A process for protecting a surgical site from infection according to claim 1 wherein the local concentration within adjacent adipose tissue for up to the first half hour of administration is greater than the systemic concentration of the agent by a factor of at least 10.

5. A process for protecting a surgical site from infection according to claim 4 wherein the local concentration within adjacent adipose tissue for up to the first half hour of administration is greater than the systemic concentration of the agent by a factor of at least 50.

6. A process for protecting a surgical site from infection according to claim 4 wherein the local concentration within adjacent adipose tissue for up to the first half hour of administration is greater than the systemic concentration of the agent by a factor of at least 100.

7. A process for protecting a surgical site from infection according to claim 1 wherein the local concentration after the first half hour of administration is greater than 500 μ

g/ml and the systemic concentration is less than about 40 μ

g/ml.

8. A process for protecting a surgical site from infection according to claim 1 wherein the local concentration after the first half hour of administration is greater than 500 μ

g/ml and the systemic concentration is less than about 10 μ

g/ml.

9. A process for protecting a surgical site from infection according to claim 1 wherein the local concentration after the first half hour of administration is greater than 250 μ

g/ml and the systemic concentration is less than about 30 μ

g/ml.

10. A process for protecting a surgical site from infection according to claim 1 wherein the antibiotics are encapsulated in a delivery system selected from the group consisting of vesicles and nanoparticles.

11. A process for protecting a surgical site from infection according to claim 10 in which ultrasonic energy enhances the dispensing and delivery of the therapeutically active form of antibiotic from the delivery system.

15. A process for selective administration of a therapeutic agent to selected tissue at high local doses according to claim 5 wherein the therapeutic agent is at least one of analgesic, anti-inflammatory agent and a agent that is preferably toxic to tumors over healthy tissue.

21. A process for selective administration of a therapeutic agent to selected tissue at high local doses according to claim 5 wherein the therapeutic agent is at least one of analgesic, anti-inflammatory agent and a agent that is preferably toxic to tumors over healthy tissue.

12. A process for selective administration of a therapeutic agent to selected tissue at high local doses, the process comprising the steps of:

a) defining within a surgical or treatment field an incision line to access the selected tissue,

b) making a first small incision at or about the incision line,

c) injecting a quantity of the therapeutic agent in or with a fluid subcutaneously in and about the selected tissue,

d) broadcasting energy transcutaneously to disperse therapeutic agent and fluid subcutaneously,

e) wherein within the time period between the first half hour after injection and the first hour after injection the local concentration of the agent is greater than the systemic concentration by a factor of at least 10.

13. A process for selective administration of a therapeutic agent to selected tissue at high local doses according to claim 12 wherein the selected tissue is an inflamed joint.

14. A process for selective administration of a therapeutic agent to selected tissue at high local doses according to claim 12 wherein the selected tissue is a soft tissue tumor.

16. A process for selective administration of a therapeutic agent to selected tissue at high local doses according to claim 12

wherein within the time period between the first half hour after injection and the first hour after injection the local concentration of the agent is greater than the systemic concentration by a factor of at least 10.

17. A process for selective administration of a therapeutic agent to selected tissue at high local doses, the process comprising the steps of:

a) defining within a surgical or treatment field an incision line to access the selected tissue,

b) making a first small incision at or about the incision line,

c) injecting a quantity of the therapeutic agent in or with a fluid subcutaneously in and about the selected tissue,

d) broadcasting energy transcutaneously to disperse therapeutic agent and fluid subcutaneously,

e) wherein the systemic concentration of the agent remains below 1/10 th the local concentration a half hour after injection.

18. A process for selective administration of a therapeutic agent to selected tissue at high local doses according to claim 17 wherein the systemic concentration of the agent remains below 1/50 th the local concentration a half hour after injection.

19. A process for selective administration of a therapeutic agent to selected tissue at high local doses according to claim 17 wherein the selected tissue is an inflamed joint.

20. A process for selective administration of a therapeutic agent to selected tissue at high local doses according to claim 17 wherein the selected tissue is a soft tissue tumor.