Iontophoresis drug delivery system and method for denervation of the renal sympathetic nerve and iontophoretic drug delivery

• US 9,919,144 B2
• Filed: 05/06/2015
• Issued: 03/20/2018
• Est. Priority Date: 04/08/2011
• Status: Expired due to Fees

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Inventors: Meyer, Peter
• Primary Examiner(s): Berdichevsky, Aarti B
• Application Number:
  US14/705,318
• Publication Number:
  US 20150231386A1
• Time in Patent Office: 1,049 Days
• 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 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04
• CPC Class Codes: A61N 1/044 Shape of the electrode
• CPC Class Codes: A61N 1/0444 Membrane
• CPC Class Codes: A61N 1/0448 Drug reservoir
• CPC Class Codes: A61N 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
• CPC Class Codes: A61N 1/303 Constructional details electrodes for external use A61N1/0428
• 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 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system

Abstract

An iontophoresis drug delivery system and method for denervation of the renal sympathetic nerve and iontophoresis drug delivery. The system includes an iontophoresis catheter fitted with a drug coated balloon. The iontophoresis catheter includes a balloon near its distal tip or end that contacts the vessel wall circumferentially when inflated. One or more electrodes are associated with a surface of the balloon, and may be disposed on an outer surface of the balloon. The electrodes are operably coupled to an energy source configured to produce a bipolar or monopolar electric field between two balloon electrodes and/or between one balloon electrode and another electrode placed in contact with a part of the patient'"'"'s body. During use, the disclosed drug-delivery catheter produces an electric potential gradient within adjacent tissue, that, in turn, facilitates iontophoresis delivery of a drug. The disclosed catheter can also include a store of one or more drugs to be delivered to the targeted tissue.

Claims

1. A method of treating a human patient, the method comprising:

placing a drug delivery catheter in a renal artery of the patient, the catheter including a balloon disposed toward the distal end of the catheter and at least one electrode disposed on an outer surface of the balloon, wherein placing the drug delivery catheter includes inflating the balloon into circumferential contact with the wall of the renal artery;

producing an electric potential between the electrode and nerves adjacent a wall of the renal artery; and

administering a drug to the nerves via the electric potential, wherein administering the drug includes disrupting a cover layer covering one or more wells on the surface of the balloon, the one or more wells storing the drug, and the disruption of the cover layer releasing the drug in the vicinity of the one or more electrodes.

2. The method of claim 1, wherein administering the drug includes delivering the drug around a circumference of the wall of the renal artery.

3. The method of claim 1, wherein producing the electric potential includes generating an electric field having a continuous current.

4. The method of claim 1, wherein the at least one electrode includes a first electrode and a second electrode and producing the electric potential includes generating an electric field between the first electrode and the second electrode.

5. The method of claim 1, wherein disrupting the cover layer includes melting the cover layer by resistive heating through application of energy from the at least one electrode.

6. The method of claim 1, wherein disrupting the cover layer includes applying pressure to the cover layer by pressing the balloon against the wall of the renal artery.

7. The method of claim 1, wherein the drug includes guanethidine formulated in an ionic form with a +2 charge.

8. The method of claim 7, wherein the drug further includes dimethyl sulfoxide.

9. The method of claim 7, wherein the drug further includes a vasovasorum constrictor.