Apparatus and method for reducing subcutaneous fat deposits by electroporation

• US RE43,009 E1
• Filed: 10/01/2009
• Issued: 12/06/2011
• Est. Priority Date: 08/17/2000
• Status: Expired due to Term

• Current Assignee: AngioDynamics, Inc.
• Original Assignee: AngioDynamics, Inc.
• Inventors: Chornenky, Victor I., Jaafar, Ali
• Primary Examiner(s): Getzow, Scott
• Application Number:
  US12/572,005
• Time in Patent Office: 796 Days
• Field of Search: 607/2, 607/3, 607/72, 607/115, 607/116, 607/148, 607/152, 607/153, 600373-375, 600/377, 600/378, 600/381, 604/20, 128/907
• US Class Current: 607/2
• CPC Class Codes: A61B 2018/00613 Irreversible electroporation reversible electroporation A61N1/327
• CPC Class Codes: A61N 1/0502 Skin piercing electrodes
• 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

Abstract

An apparatus and method for minimally invasive treatment of deep subcutaneous fat deposits in lieu of cosmetic surgery is disclosed. The apparatus comprises a high voltage pulse generator connected to two or more needle electrodes at least one of which is configured for placement deeply under the skin in a treatment site of the patient'"'"'s body. High voltage pulses, delivered to the electrodes, create an electric field that kills subcutaneous fat cells.

Claims

1. An apparatus for reducing subcutaneous fat deposits by electroporation comprising:

an applicator comprising a plurality of needle electrodes adapted for penetrating the skin of a patient and applying a high amplitude pulsed electric field to the area of the subcutaneous volume of fat tissue to be treated by electroporation, at least one of said plurality of needle electrodes includes insulated portions and a pair of uninsulated needle portions axially separated along said needle electrode, wherein

said uninsulated needle portions form axially separate electrodes of opposite polarity; and

said insulated portions include proximal, distal, and central insulated portions, said proximal insulated portion being provided for insulating the skin of the patient during an electroporation treatment, said distal insulated portion being provided to avoid spark discharges to an adjacent needle electrode and said central insulated portion separating said electrodes, wherein said electrodes are disposed on said needle electrode such that they are disposed within the subcutaneous fat deposit during treatment;

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

connectors connecting said generator of high voltage electrical pulses with corresponding needle electrodes placed under the skin.

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

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

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

5. An apparatus according to claim 1 wherein high voltage pulses are rectangularly balanced.

6. A method for reducing deep subcutaneous fat deposits by electroporation comprising:

providing an applicator comprising a set of high voltage needle electrodes adapted for penetrating the skin of a patient and applying a high amplitude pulsed electric field to the area of the subcutaneous volume of tissues to be treated by electroporation, at least one of said plurality of needle electrodes including insulated portions and a pair of uninsulated needle portions axially separated along said needle electrode, wherein

said uninsulated needle portions form axially separated electrodes of opposite polarity; and

said insulated portions include proximal, distal, and central insulated portions, said proximal insulated portion being provided for insulating the skin of the patient during an electroporation treatment, said distal insulated portion being provided to avoid spark discharges to an adjacent needle electrode and said central insulated portion separating said electrodes, wherein said electrodes are disposed on said needle electrode such that they are disposed within the subcutaneous fat deposit during treatment;

providing a generator of high voltage pulses for applying pulsed electric field to the 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;

connecting said generator of high voltage electrical pulses with corresponding needle electrodes placed in the deep subcutaneous fat tissue; and

applying high voltage pulses via said set of needle electrodes with an amplitude sufficient to cause death to subcutaneous fat cells.

7. An apparatus for reducing deep subcutaneous fat deposits in a predetermined treatment volume beneath a predetermined area of a patient'"'"'s skin by electroporation, said apparatus comprising:

a set of needle electrodes, wherein said set of electrodes comprises;

an array of electroporation needle electrodes, said electroporation needle electrodes being provided for applying a pulsed electric field to the subcutaneous volume of tissues, wherein said needle electrodes are arrayed such that each needle electrode is adjacent to at least one needle electrode having the opposite polarity and wherein the needle electrodes include proximal and distal insulated portions and a central uninsulated portion configured to insulate the skin and dispose the uninsulated portion in the subcutaneous fat deposit;

a generator of high voltage pulses for applying a pulsed electric field to the predetermined area via said 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, and

connectors connecting said generator of high voltage electrical pulses with corresponding electroporation electrodes.

8. An apparatus according to claim 7 wherein high voltage pulses are electrically balanced in such a manner that in average no direct current is passing through the treatment volume.

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

10. Apparatus for reduction of subcutaneous fat deposits in a predetermined treatment zone beneath a predetermined area of a patient'"'"'s skin by electroporation, said apparatus comprising:

a plurality of electrodes, wherein at least one of said electrodes is a subcutaneous electrode configured for placement under the skin and within the treatment zone and wherein at least one of said electrodes is a patch electrode applied to the patient'"'"'s skin;

a generator of high voltage pulses for applying a pulsed electric field to the treatment zone via said electrodes, wherein the applied pulses generate an electric field above the upper electroporation limit for subcutaneous fat cells in the treatment zone, and

connectors connecting said generator of high voltage electrical pulses with said electrodes.

11. An apparatus according to claim 10 wherein said subcutaneous electrode is a needle electrode adapted for penetrating the skin of a patient, said needle electrode including insulated portions and a pair of uninsulated needle portions axially separated alone said needle electrode, wherein

said uninsulated needle portions form axially separate electrodes of opposite polarity;

and

said insulated portions include proximal, distal, and central insulated portions, said proximal insulated portion being provided for insulating the skin of the patient during an electroporation treatment, said distal insulated portion being provided to avoid spark discharaes to an adjacent needle electrode and said central insulated portion separating said electrodes, wherein said electrodes are disposed on said needle electrode such that they are disposed within the subcutaneous fat deposit during treatment.

12. An apparatus according to claim 10 wherein said apparatus includes at least a pair of subcutaneous electrodes.

13. An apparatus according to claim 12 wherein each of said at least one pair of subcutaneous electrodes is formed on a needle comprising proximal and distal insulated portions and wherein said subcutaneous electrode is formed therebetween said insulated portions on each needle.

14. An apparatus according to claim 10 and further including plurality of subcutaneous electrodes and wherein said plurality of subcutaneous electrodes comprises an array of electrodes each configured for placement under the skin and within the treatment zone, said electrodes being provided with alternating positive and negative polarities.

15. An apparatus according to claim 10 wherein the high voltage pulses are electrically balanced in such a manner that in average no direct current is passing through the treatment zone.

16. An apparatus according to claim 10 wherein the high voltage pulses are rectangularly balanced.

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

22. An apparatus according to claim 17 wherein the amplitude of the electric field applied to the treated volume falls in a range of about 20 Volt/mm to about 2000 Volt/mm.

18. A method for reducing the number of subcutaneous fat cells in a predetermined treatment zone by electroporation of the cells in the treatment zone, said method comprising:

disposing at least a first electrode in the treatment zone;

disposing a second electrode on the patient'"'"'s skin in close proximity to the first electrode; and

applying high voltage electric field pulses via the first and second electrodes with an amplitude sufficient to cause death to subcutaneous fat cells by electroporation.

19. A method according to claim 18 wherein said at least one treatment zone electrode is a needle including an electrode.

20. A method according to claim 18 and further including a needle, wherein said plurality of electrodes comprises a pair of spaced apart electrodes disposed on said needle.

21. A method according to claim 18 wherein the high voltage pulses are electrically balanced in such a manner that in average no direct current is passing through the treatment zone.

23. An apparatus according to claim 18 wherein said high voltage pulses have a duration in a range of about 10 microseconds to about 10 millisecond.

24. An apparatus according to claim 23 wherein the amplitude of the electric field applied to the treated volume falls in a range of about 20 Volt/mm to about 2000 Volt/mm.