Electroporation microneedle and methods for its use

• US 7,127,284 B2
• Filed: 06/10/2002
• Issued: 10/24/2006
• Est. Priority Date: 06/11/2001
• Status: Active Grant

• Current Assignee: Mercator MedSystems, Inc.
• Original Assignee: Mercator MedSystems, Inc.
• Inventors: Seward, Kirk Patrick
• Primary Examiner(s): Thanh, LoAn H.
• Application Number:
  US10/167,239
• Publication Number:
  US 20020198512A1
• Time in Patent Office: 1,597 Days
• Field of Search: 604 20- 22, 604/264, 604/272, 606/32, 606/34, 606/41
• US Class Current: 604/20
• CPC Class Codes: A61M 2025/0093 wherein at least one needle is a microneedle
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 37/0015 by using microneedles
• 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

Abstract

Electroporation of cells in target tissues is performed using microneedles having integral electrode structures. In a first embodiment, a pair of electrode structures are disposed on opposite sides of a substance delivery opening on a needle or other tissue-penetrating shaft. In a second embodiment, a first electrode structure is disposed on the needle and a second electrode structure is disposed on an attached base. The electrode structures are spaced closely together and relatively low voltages are applied to achieve electroporation-enhanced substance delivery.

Claims

1. An electroporation apparatus comprising:

a base;

an elongate shaft having an axis, a distal end, a proximal end attached to the base, and a lumen extending from a proximal location to an opening at a distal location on the shaft, the distal end of the elongate shaft adapted to penetrate tissue;

a first electrode structure disposed on the shaft near the distal location; and

a second electrode structure disposed on the base and spaced-apart axially from the first electrode structure to establish an electric field between the first electrode structure and the second electrode structure, wherein the shaft has an outer diameter in the range from 10 μ

m to 1 mm and a length in the range from 0.1 mm to 10 mm.

2. The electroporation apparatus as in claim 1, wherein the first electrode structure has an exposed electrode surface area in the range from 0.001 mm² to 4 mm² and the second electrode structure has an exposed electrode surface area in the range from 0.01 mm² to 100 mm².

3. The electroporation apparatus as in claim 2, wherein the first electrode structure and the second electrode structure are spaced-apart by a distance in the range from 10 μ

m to 10 mm.

4. The electroporation apparatus as in claim 1, wherein the base comprises a syringe.

5. The electroporation apparatus as in claim 1, wherein the opening is through a side wall of the shaft.

6. The electroporation apparatus as in claim 1, further comprising an alternating current power supply adapted to deliver electroporation current to the electrode structures at a voltage in the range from 1 V to 30 kV.

7. The electroporation apparatus as in claim 1, further comprising a catheter body coupled with the base to urge the elongate shaft along the axis.