System and method for electrical control of bacteria

Patent metadata

Field	Value
Publication number	US-10660979-B2
Application number	US-201615754439-A
Country	US
Kind code	B2
Filing date	Aug 25, 2016
Priority date	Aug 26, 2015
Publication date	May 26, 2020
Grant date	May 26, 2020

Abstract

A system and method for controlling microbial growth on and in medical devices and implants, especially biofilm infections, involves using pulsed electric fields (PEF). To eradicate at least a portion of a biofilm on a medical implant, for example, 1500 volts can be applied through an electrode system, with pulse duration of 50 μs and pulse delivery frequency of 2 Hz. In the clinical setting, systemic microbial therapy can be combined with PEF to achieve a synergistic effect leading to improved eradication of infections.

First claim

What is claimed is:

1. A method for disinfecting a medical device using pulsed electric fields, the method including the steps of:
a. positioning an electrode system at a medical device with a microbial biofilm; and
b. applying a pulsed electric field to the microbial biofilm to eradicate at least a portion of the microbes in the biofilm, wherein:
1) the pulsed electric field has an electric field strength of at least 100 V/mm; and
2) at least 100 pulses are applied to the biofilm at a pulse frequency of at least 1 per second.

2. The method of claim 1 wherein the electrode system is positioned at a synthetic mesh implant in a patient.

3. The method of claim 1 further including the steps of:
a. characterizing the microbial biofilm to be treated;
b. entering one or more characteristics of the biofilm into a disinfection system; and
c. receiving one or more suitable protocols based on the one or more characteristics, each protocol defining one or more of:
1) a number of pulses;
2) a pulse duration;
3) a voltage; and
4) a pulse frequency.

4. The method of claim 1 further including the step of choosing a protocol to be used in applying the pulsed electric field, the protocol defining magnitude or duration for a subset of pulses in the pulsed electric field.

5. The method of claim 1 further including the step of defining a protocol to be used in applying the pulsed electric field, the protocol defining one or more parameters from the group consisting of:
1) number of pulses;
2) pulse duration;
3) voltage; and
4) pulse frequency.

6. The method of claim 1 wherein the medical device is placed in a device receptacle of a disinfection system to position the electrode system at the medical device, the electrode system being located at the device receptacle.

7. The method of claim 1 wherein the electrode system is a concentric electrode system.

8. The method of claim 1 wherein the electrode system includes an array of electrode needles.

9. The method of claim 1 wherein the pulsed electric field is applied at 1000 volts or greater.

10. The method of claim 1 wherein the electric field strength is at least 200 V/mm.

11. The method of claim 1 wherein the pulsed electric field is applied at a pulse duration of at least 25 μs.

12. The method of claim 1 wherein the medical device is a synthetic mesh, the method further including the step of diagnosing a mesh infection.

13. The method of claim 1 wherein the medical device is a medical implant.

14. The method of claim 1 further including the step of using an antimicrobial therapy in combination with the pulsed electric field.

15. The method of claim 14 wherein the antimicrobial therapy is a systemic antibacterial therapy.

16. The method of claim 1 further including the step of:
a. using a scope to locate and visual a biofilm on an implanted medical device to be disinfected; and
b. inserting the electrode system in a patient and positioning the electrode system at the implanted medical device.

17. The method of claim 1 further including the step of selecting one or more parameters of the pulsed electric field to be used to disinfect the implanted medical device, wherein:
a. the selection is based on one or more characteristics of the biofilm; and
b. the one or more parameters includes:
1) a number of pulses; and
2) a pulse duration.

18. A disinfection system for disrupting microbial growth on non-biological devices, the system including:
a. a pulse generator for generating pulsed electric fields,
the pulse generator generating a voltage of 1000 volts or greater; and

b. a processing unit for controlling the pulse generator to apply pulsed electric fields to a microbial biofilm to eradicate at least a portion of the microbes therein, the processing unit being configured to apply:
1) a pulsed electric field with an electric field strength of at least 100 V/mm; and
2) at least 100 pulses with a pulse duration of at least 25 μs and a pulse frequency of at least 1 Hz.

19. The system of claim 18 wherein the processing unit is further configured to:
a. receive one or more characteristics of a biofilm to be eradicated;
b. determine one or more suitable protocols based on the one or more characteristics, each protocol defining one or more parameters from the group consisting of:
1) number of pulses;
2) pulse duration;
3) voltage; and
4) pulse frequency.

20. The system of claim 19 wherein the processing unit is further configured to:
a. receive a protocol selection from among the one or more suitable protocols; and
b. control the pulse generator to apply a pulsed electric field with parameters of the selected protocol.

21. The system of claim 18 further including:
a. a scope for capturing images of an implanted device to be disinfected; and
b. a display configured to receive images from the scope.

22. The system of claim 18 further including an electrode system coupled to the pulse generator, the electrode system having an array of needles for application of the pulse electric field.

Assignees

• Yarmush Martin L
• Austen William G
• Golberg Alexander
• Khan Saiqa L
• Massachusetts Gen Hospital

Inventors

• Yarmush Martin L
• Austen William G
• Golberg Alexander
• Khan Saiqa L

Classifications

• A61L2/03 Primary

  Electric current · CPC title

• A61M2025/0019

  Cleaning catheters or the like, e.g. for reuse of the device, for avoiding replacement · CPC title

• A61B18/14

  Probes or electrodes therefor · CPC title

• A61B18/00

  Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body (eye surgery A61F9/007; ear surgery A61F11/00) · CPC title

• A61N1/20

  continuous direct currents · CPC title