Apparatus for electroporation mediated delivery for drugs and genes

• US 6,516,223 B2
• Filed: 05/18/2001
• Issued: 02/04/2003
• Est. Priority Date: 08/01/1997
• Status: Expired due to Term

• Current Assignee: Oncosec Medical Incorporated (China Grand Pharmaceutical & Healthcare Holdings Ltd.)
• Original Assignee: Genetronics, Inc. (Inovio Pharmaceuticals, Inc.)
• Inventors: Hofmann, Gunter A.
• Primary Examiner(s): Kennedy, Sharon
• Application Number:
  US09/861,016
• Publication Number:
  US 20020065480A1
• Time in Patent Office: 627 Days
• Field of Search: 604/890.1, 604/19-22, 604/500, 604/501, 128/898, 607/2, 607/100, 607/116, 607/154, 435/173.5, 435/173.6
• US Class Current: 604/21
• CPC Class Codes: A61N 1/0502 Skin piercing electrodes
• CPC Class Codes: A61N 1/325 for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body electrodes for external use A61N1/0428
• CPC Class Codes: A61N 1/327 for enhancing the absorption properties of tissue, e.g. by electroporation
• CPC Class Codes: C12M 35/02 Electrical or electromagnetic means, e.g. for electroporation or for cell fusion

Abstract

A device for in vivo electroporation therapy comprising an electrode applicator with at least two pairs of electrodes arranged relative to one another to form an array and a power supply. The device is used to generate an electric field in a biological sample and effect introduction of selected molecules into cells of the sample.

Claims

1. A device, comprising:

(a) an electrode applicator having at least two pairs of electrodes arranged relative to one another to form a desired array;

(b) an applicator handle having a first end detachably engaged to the electrode applicator and a second end positioned to receive at least one electrical signal from a power supply, the applicator handle configured to supply the at least one electrical signal to the electrode applicator, and

(c) a power supply to provide at least one electrical signal to the second end of the applicator handle configured to supply the signal to the electrode applicator;

wherein, when selected molecules are provided to a biological sample comprising cells and at least two pairs of electrodes in the electrode applicator are in electrical contact with the biological sample, the electrode applicator is operable to provide separately applied pulses of high amplitude electric signals to said at least two pairs of electrodes, but not all electrodes if there are more than two pairs of electrodes, simultaneously and proportionately to the distance between said electrodes of a pair to generate a nominal field strength of about 10 V/cm to about 1500 V/cm in the biological sample and effect introduction of the selected molecules into cells of the sample without permanently damaging the cells.

2. The device of claim 1, wherein the electrode applicator includes a shield element that separates the applicator handle from the electrode applicator.

3. The device of claim 1, wherein the electrode applicator produces electrical pulses between two electrodes according to a set of predetermined electrode configurations.

4. The device of claim 1, wherein the applicator handle further comprises an identification circuit connected to determine a number of electrodes in the electrode applicator and desired electrical signal parameters for the applicator.

5. The device of claim 1, wherein the power supply is a control module connected to the applicator handle to supply the at least one electrical signal and provide at least one of the following electrical treatment parameters to be used with the electrode applicator:

electrode voltage setpoint, pulse length, pulse shape, a number of pulses, and switching sequence.

6. The device of claim 5, wherein the control module produces the at least one electrical signal according to a spacing of the electrodes in the electrode applicator.

7. The device of claim 5, wherein the control module produces the at least one electrical signal according to a number of the electrodes in the electrode applicator.

8. The device of claim 1, wherein the pulses produced by the power supply have a pulse width from about 10 microsec to about 100 msec.

9. The device of claim 1, wherein at least one electrode in the electrode applicator is configured to transmit a liquid substance, having the selected molecules, to the biological sample and the applicator handle includes a liquid channel for delivering the liquid substance to the electrode applicator.

10. The device of claim 1, wherein each electrode comprises a base portion that is directly engaged to the electrode applicator and is covered with a layer of electrically insulating material preventing electrical contact with the biologic sample and a desired portion of a tip portion that is not insulated and allows electrical contact with the biological sample.