Apparatus and method for reducing subcutaneous fat deposits by electroporation with improved comfort of patients

• US 20030149451A1
• Filed: 02/11/2003
• Published: 08/07/2003
• Est. Priority Date: 08/17/2001
• Status: Active Grant

• Current Assignee: AngioDynamics, Inc.
• Original Assignee: Midwest Medical Physics, LLC
• Inventors: Chomenky, Victor I., Jaafar, Ali
• Granted Patent: US 6,697,670 B2
• Time in Patent Office: Days
• US Class Current: 607/3
• CPC Class Codes: A61N 1/0412 Specially adapted for transcutaneous electroporation, e.g. including drug reservoirs
• CPC Class Codes: A61N 1/0424 Shape of the electrode
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/327 for enhancing the absorption properties of tissue, e.g. by electroporation
• CPC Class Codes: A61N 1/328 for improving the appearance of the skin, e.g. facial toning or wrinkle treatment
• CPC Class Codes: A61N 1/36021 for treatment of pain

Abstract

An apparatus and method for non-invasive treatment in lieu of cosmetic surgery is disclosed. The apparatus comprises a combination of a high and low voltage pulse generators connected to two or more electrodes placed on a treatment site of the patient'"'"'s body. High voltage pulses, delivered to the electrodes, create an electric field that kills subcutaneous fat cells. Low voltage pulses, delivered to the same or individual electrodes provide transcutaneous electrical nerve stimulation (TENS), blocking the signals of discomfort or pain that may arise from the high voltage pulsing.

Claims

1. An apparatus for reducing subcutaneous fat deposits by electroporation with improved comfort of patients comprising:

an applicator comprising two sets of electrodes, the first and the second, said first set of electrodes are high voltage electrodes adapted for engaging the skin of a patient and applying a high amplitude pulsed electric field to the area of skin and the subcutaneous volume of tissues to be treated by electroporation, said second set of electrodes adapted for transcutaneous electrical nerve stimulation of the skin and the volume of the subcutaneous tissue over an area generally larger than the area of electroporation treatment;

a generator of high voltage pulses for applying pulsed electric field to the first set of electrodes, said pulses generating an electric field above the upper electroporation limit for subcutaneous fat cells in the volume of the subcutaneous tissue to be treated;

a generator for generating low voltage pulses for applying pulsed electric field to the second set of electrodes, said amplitude of the electric field is adapted for Transcutaneous Electrical Nerve Stimulation (TENS) of the skin and subcutaneous tissue;

a synchronizing circuit connected to said high and said low voltage pulse generators and providing triggering of the high voltage pulses with a controllable delay after the TENS pulses, and

connectors connecting said generators of high and low voltage electrical pulses with corresponding high and low voltage electrodes.

2. An apparatus according to claim 1 wherein the two sets of electrodes in the applicator share at least some electrodes to which both the high voltage pulses for electroporation and low voltage pulses for TENS are applied.

3. An apparatus according to claim 1 wherein said high voltage pulses have duration in a range of 10 microseconds to 1 millisecond.

4. An apparatus according to claim 1 wherein the amplitude of the electric field applied to the treated volume falls in a range of 20 Volt/mm to 2000 Volt/mm.

5. An apparatus according to claim 1 wherein said delay of the high voltage pulses relatively to the TENS pulses falls into the time range of 0 to 1.5 milliseconds.

6. An apparatus according to claim 1 wherein both low and high voltage pulses are electrically balanced in such a manner that in average no direct current is passing through the treatment volume.

7. An apparatus according to claim 1 wherein high voltage pulses are rectangular balanced.

8. An apparatus according to claim 1 wherein said low voltage pulses have duration in a range of 10 to 200 microseconds.

9. An apparatus according to claim 1 wherein said low voltage pulses have repetition rate in a range of 4 to 120 Hertz.

10. An apparatus according to claim 1 wherein said low voltage pulses have amplitude in the range from 10 to 100 V.

22. The method of claim 1 wherein the electroporation pulses are rectangularly balanced.

11. A method for reducing subcutaneous fat deposits by electroporation with improved comfort of patients comprising:

providing an applicator comprising first and second sets of electrodes, wherein first set of electrodes are high voltage electrodes are configured for engaging the skin of a patient and applying a high amplitude pulsed electric field to the area of skin and the subcutaneous volume of tissues to be treated by electroporation and wherein said second set of electrodes are configured for transcutaneous electrical nerve stimulation of the skin and the volume of the subcutaneous tissue over an area generally larger than the area of electroporation treatment;

providing a generator of high voltage pulses for applying pulsed electric field to the first set of electrodes, said pulses generating an electric field above the upper electroporation limit for subcutaneous fat cells in the volume of the subcutaneous tissue to be treated;

providing a generator for generating low voltage pulses for applying pulsed electric field to the second set of electrodes, said amplitude of the electric field providing transcutaneous electrical nerve stimulation (TENS) of the skin and subcutaneous tissue;

providing a synchronizing circuit connected to said high and said low voltage pulse generators and providing triggering of the high voltage pulses with a controllable delay after the TENS pulses;

connecting said generators of high and low voltage electrical pulses with corresponding high and low voltage electrodes; and

applying TENS pulses via said second set of electrodes to the area in and around of the area to be treated and high voltage pulses via said first set of electrodes with an amplitude sufficient to cause death to subcutaneous fat cells.

12. An apparatus for reducing subcutaneous fat deposits in a predetermined treatment volume beneath a predetermined area of a patient'"'"'s skin by electroporation with improved comfort for the patient, said apparatus comprises:

first and second electrode sets, wherein said first electrode set comprises;

at least a pair of electroporation electrodes, said electroporation electrodes being provided for applying a pulsed electric field to the predetermined area of skin and the subcutaneous volume of tissues;

and

wherein said second electrode set comprises;

at least a pair of TENS electrodes, said TENS electrodes being configured for transcutaneous electrical stimulation of the patient over a tissue volume including at least the predetermined treatment volume;

a generator of high voltage pulses for applying a pulsed electric field to the predetermined area via said first electrode set, said pulses generating an electric field above the upper electroporation limit for subcutaneous fat cells in the volume of the subcutaneous tissue to be treated;

a generator for generating low voltage pulses for applying a pulsed electric field to the predetermined area via said second electrode set, wherein the amplitude of the low voltage electric field is chosen to provide transcutaneous electrical nerve stimulation (TENS) of the nerves of the skin and subcutaneous tissue in an area larger than the predetermined area;

a synchronizing circuit connected to said high and said low voltage pulse generators and providing triggering of the high voltage pulses with a controllable delay after the TENS pulses, and

connectors connecting said generators of high and low voltage electrical pulses with corresponding electroporation and TENS electrodes.

13. An apparatus according to claim 12 wherein the two sets of electrodes in the applicator share at least some electrodes to which both the high voltage pulses for electroporation and low voltage pulses for TENS are applied.

14. An apparatus according to claim 12 wherein said delay of the high voltage pulses relatively to the TENS pulses falls into the time range of 0 to 1.5 milliseconds.

15. An apparatus according to claim 12 wherein both low and high voltage pulses are electrically balanced in such a manner that in average no direct current is passing through the treatment volume.

16. An apparatus according to claim 12 wherein high voltage pulses are rectangular balanced.

17. A method for reducing subcutaneous fat deposits in a treatment volume by electroporation with improved patient comfort, said method comprising:

applying a plurality of electroporation electric field pulses to the treatment volume to induce subcutaneous fat cell death by electroporation; and

applying a plurality of TENS electric field pulses at least to the treatment volume to improve patient comfort by transcutaneous electric nerve stimulation at least in the treatment volume.

18. The method of claim 17 wherein the TENS electric field is applied to at least the treatment volume prior to application of the electroporation field.

19. The method of claim 17 wherein the applied electroporation and TENS pulses are synchronized such that a TENS pulse is applied to at least to the treatment volume prior to application of an electroporation pulse.

20. The method of claim 19 wherein application of an electroporation pulse relative to the application of a TENS pulse is delayed by a time in the range of about 0 to about 1.5 milliseconds

21. The method of claim 17 wherein both electroporation and TENS pulses are electrically balanced in such a manner that in average no direct current is passing through the treatment volume.