Iontophoresis, electroporation and combination catheters for local drug delivery to arteries and other body tissues

• US 6,219,577 B1
• Filed: 02/19/1999
• Issued: 04/17/2001
• Est. Priority Date: 04/14/1998
• Status: Expired due to Fees

• Current Assignee: GMP Drug Delivery Incorporated
• Original Assignee: Global Vascular Concepts, Inc.
• Inventors: Freear, Steven, Crawford, Neville, Brown, Charles L. III
• Primary Examiner(s): Nguyen, Anhtuan T.
• Assistant Examiner(s): Thompson, Michael M
• Application Number:
  US09/253,272
• Time in Patent Office: 788 Days
• Field of Search: 604/96, 604/101, 604/20, 604/21, 604/22, 604/501, 606/113, 606/198, 606/127
• US Class Current: 604/20
• CPC Class Codes: A61N 1/306 Arrangements where at least part of the apparatus is introduced into the body

Abstract

Catheter-based devices for enhancing the local delivery of drugs, pharmaceuticals, plasmids, genes, and other agents into the wall tissues of tubular compartments of the living body. One catheter device provides an electrical driving force that can increase the rate of migration of drugs and other therapeutic agents out of a polymer matrix into body tissues and cells using iontophoresis only. Another device uses iontophoresis only, electroporation only, or combined iontophoresis and electroporation. In the latter device, the two procedures may be applied sequentially in any order without removing or repositioning the catheter.

Claims

1. A catheter-based device for enhancing the local delivery of a treatment agent into target tissues of a body vesicle or organ comprising:

a catheter having a proximal end, a distal end and a middle region; and

an electrode network at the distal end of the catheter comprising a plurality of electrodes and having a proximal end, a distal end and a middle region;

wherein the electrode network is constructed and arranged such that when the electrode network is in a relaxed position, the electrodes lie substantially flat and when the electrode network is in an expanded position, the electrodes are closely juxtaposed to the target tissues without occluding fluid flow through the body vesicle; and

a polymer matrix incorporating the treatment agent is located around at least the middle region of the electrode network of the catheter.

2. The catheter-based device of claim 1, wherein the electrodes comprise metal wire.

3. The catheter-based device of claim 2, wherein the electrodes comprise stainless steel.

4. The catheter-based device of claim 2, wherein the electrode network further comprises polyester monofilaments intercalated between the metal wire electrodes.

5. The catheter-based device of claim 2, wherein the electrodes have a thickness of from about 0.10 to about 0.20 mm.

6. The catheter-based device of claim 1, wherein the electrodes comprise a plurality of printed circuit board electrode strips.

7. The catheter-based device of claim 6, wherein the printed circuit board electrode strips comprise a conductive metal layer attached to a base material.

8. The catheter-based device of claim 7, wherein the metal layer is copper.

9. The catheter-based device of claim 7, wherein the base material is polyimide.

10. The catheter-based device of claim 6, wherein the printed circuit board electrode strips are formed by a process comprising:

attaching a flat metal sheet to a base material sheet to form a rectangular sheet having one side longer than the other;

etching electrode tracks and cutting parallel slots in the rectangular sheet to form the plurality of printed circuit board strips; and

rolling the rectangular sheet such that the rolled sheet is able to comprise the electrode network.

11. The catheter-based device of claim 6, wherein the printed circuit board electrode strips are from about 0.15 to about 0.3 mm in width.

12. The catheter-based device of claim 1, further comprising a ferrule located at the distal end of the electrode network and a ferrule located at the proximal end of the electrode network.

13. The catheter-based device of claim 12, wherein the distal end ferrule and the proximal end ferrule are constructed and arranged such that the distal end ferrule is fixed on the catheter while the proximal end ferrule is capable of sliding axially to and fro along the catheter thereby causing the electrode network to be either in the relaxed position or the expanded position.

14. A method of delivering a treatment agent into target tissues of a body vesicle comprising:

applying a treatment agent encompassed within the polymer matrix to at least a portion of the electrode network of the catheter-based device of claim 1;

expanding the electrode network such that the electrodes closely juxtapose the target tissues without occluding fluid flow through the body vesicle; and

applying means for driving the treatment agent from the electrode network into the tissue walls.

15. The method of claim 14, wherein the means for driving the treatment agent from the electrode network into the target tissues comprise iontophoretic means.

16. The method of claim 15, further comprising electroporation means to further drive the treatment agent from the electrode network into the target tissues.

17. The method of claim 14, wherein the means for driving the treatment agent from the electrode network into the target tissues comprise electroporation means.

18. The method of claim 14, wherein the treatment agent is applied to at least a portion of the electrode network by admixing the treatment agent within the polymer matrix and coating the admixture onto the surface of the electrodes.

19. The method of claim 14, wherein the treatment agent is applied to at least a portion of the electrode network by forming a visco-elastic sleeve comprising the treatment agent and the polymer material and placing the visco-elastic sleeve around the middle region of the catheter such that when the electrode network is expanded, the electrodes expand the visco-elastic sleeve outward such that an outer surface of the visco-elastic sleeve closely juxtaposes the target tissues of the bodily vesicle.

20. The method of claim 14 wherein the treatment agent is included in the polymer matrix paving applied to, or polymerized in situ on, the target tissues and the expanded electrode network is subsequently juxtaposed and energized to drive the agent out of the polymer matrix and into the target tissue.