Tissue electroperforation for enhanced drug delivery and diagnostic sampling

• US 7,133,717 B2
• Filed: 02/28/2001
• Issued: 11/07/2006
• Est. Priority Date: 08/25/1999
• Status: Expired due to Term

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Johnson & Johnson Consumer Companies Incorporated (Johnson & Johnson)
• Inventors: Wisniewski, Stephen J., Sun, Ying, Coston, Anthony F., Oakeson, Ralph W., Wang, Jonas C. T.
• Primary Examiner(s): Casler, Brian L.
• Assistant Examiner(s): DeSanto, Matthew F
• Application Number:
  US09/795,908
• Publication Number:
  US 20020010414A1
• Time in Patent Office: 2,078 Days
• Field of Search: 604/20, 604/21, 514/11, 600/309, 607/96, 606/27, 606/28, 606/41, 606/159
• US Class Current: 604/20
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61N 1/0428 Specially adapted for iontophoresis, e.g. AC, DC or including drug reservoirs
• CPC Class Codes: A61N 1/306 Arrangements where at least part of the apparatus is introduced into the body
• 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

Abstract

The present invention relates to a method and a device for transporting a molecule through a mammalian barrier membrane of at least one layer of cells comprising the steps of: ablating said membrane with an electric current from an array of treatment electrodes; and utilizing a driving force to move said molecule through said perforated membrane.

Claims

1. A method for transporting a molecule through a mammalian barrier membrane of at least one layer of cells comprising the steps of:

creating an air gap between an array of treatment electrodes and said membrane;

ablating said membrane with an electric current from the array of treatment electrodes wherein said electric current forms an electric arc between said treatment electrodes and said membrane; and

utilizing a driving force to move said molecule through said ablated membrane, wherein said membrane is skin.

2. A method of claim 1, wherein said molecule is a pharmaceutical transported through said membrane into said mammal.

3. A method of claim 2, wherein said pharmaceutical is selected from the group consisting of polysaccharides, peptides, proteins, and polynucleotides.

4. A method of claim 1, further comprising the step of applying a conductive material to said membrane prior to said ablation.

5. A method of claim 4, wherein said conductive material is selected from the group consisting of electrolytes, metal particles, and carbon particles.

6. A method of claim 1, wherein the voltage of said electric current is from about 5 to about 2,000 mV.

7. A method of claim 1, wherein said method further comprises the use of an indifferent electrode, where said electric current passes from said treatment electrode to said indifferent electrode.

8. A method of claim 1, wherein said electric current comprises a direct current.

9. A method of claim 1, wherein said electric current comprises an alternating current.

10. A method of claim 1, wherein said electric current has a frequency of between about 60 kHz to about 5,000 kHz.

11. A method as in claim 1, wherein the waveform of said electric current is selected from the group consisting of damped sine wave, modulated sine wave, pure sine wave, damped square wave, modulated square wave, pure square wave, direct current and a blend wave thereof.

12. A method of claim 1, wherein said membrane is the stratum corneum of a human.

13. A method of claim 1, wherein said driving force is selected from a group consisting of iontophoresis, electro-osmosis, reverse iontophoresis, electroperforation, phonophoresis, pressure gradients, heat and concentration gradients.

14. A method of claim 1, wherein said molecule in transported from within said mammal out through said membrane.

15. A method of claim 1, further comprising the step of piercing said membrane with a member selected from the group consisting of needles or blades.

16. A method of claim 1, further comprising the step of cooling said membrane prior to or during said ablation.

17. A method of claim 1, further comprising the step of applying an analgesic to said membrane prior to or during said ablation.

18. A method of claim 1, further comprising the step of monitoring the electrical resistance or impedance of said membrane in order to determine the presence of ablation in said membrane.

19. A method for transporting a molecule through a mammalian barrier membrane of at least one layer of cells comprising the steps of:

creating an air gap between an array of treatment electrodes and said membrane;

selectively energizing at least one electrode of the array of treatment electrodes with an electric current to ablate the membrane wherein there is an air gap between said treatment electrodes and said membrane and said electric current forms an electric arc between said treatment electrodes and said membrane;

sensing the depth of ablation penetration of the membrane;

comparing the sensed depth of ablation penetration with a predetermined threshold; and

utilizing a driving force to move said molecule through said ablated membrane.

20. The method of claim 19 wherein sensing the depth of penetration comprises measuring the impedance of the membrane.

21. A method of claim 19, wherein the voltage of said electric current is from about 5 to about 2,000 mV.

22. A method of claim 19, wherein said method further comprises the use of an indifferent electrode, where said electric current passes from said treatment electrode to said indifferent electrode.

23. A method of claim 19, wherein said electric current comprises a direct current.

24. A method of claim 19, wherein said electric current comprises an alternating current.

25. A method of claim 19, wherein said electric current has a frequency of between about 60 kHz to about 5,000 kHz.

26. A method of claim 19, wherein said membrane is the stratum corneum of a human.

27. A method of claim 19, wherein said driving force is selected from a group consisting of iontophoresis, electro-osmosis, reverse iontophoresis, electroperforation, phonophoresis, pressure gradients, heat and concentration gradients.

28. A method of claim 19, wherein said molecule is a pharmaceutical transported through said membrane into said mammal.

29. A method of claim 19, wherein said molecule in transported from within said mammal out through said membrane.

30. A method of claim 19, further comprising the step of applying a conductive material to said membrane prior to said ablation.