Balloon catheter method for reducing restenosis via irreversible electroporation

Abstract

Restenosis or neointimal formation may occur following angioplasty or other trauma to an artery such as by-pass surgery. This presents a major clinical problem which narrows the artery. The invention provides a balloon catheter with a particular electrode configuration. Also provided is a method whereby vascular cells in the area of the artery subjected to the trauma are subjected to irreversible electroporation which is a non-thermal, non-pharmaceutical method of applying electrical pulses to the cells so that substantially all of the cells in the area are ablated while leaving the structure of the vessel in place and substantially unharmed due to the non-thermal nature of the procedure.

Description

CROSS-REFERENCE[0001]This application claims the benefit of U.S. Provisional Application Nos. 61 / 040,110, filed Mar. 28, 2008 and 61 / 156,368, filed Feb. 27, 2009, which applications are incorporated herein by reference.GOVERNMENT RIGHTS[0002]This invention was made with government support under federal grant no. NIH R01 RR018961 awarded by the U.S. National Institutes of Health (NIH). The United States Government has certain rights in this invention.FIELD OF THE INVENTION[0003]The present invention relates to a medical device and method for the prevention of vascular re-stenosis using electroporation. More particularly, the present invention relates to a balloon catheter device with electrodes for electroporating the inner wall of a vascular structure to prevent re-stenosis.BACKGROUND OF THE INVENTION[0004]Catheters, and more particularly, balloon catheters have been used to treat stenosis of a vascular or other anatomical tubular structure. In one such procedure, called percutaneou...

AI Technical Summary

Benefits of technology

[0018]After the procedure is carried out vascular cells in the area subjected to trauma by the angioplasty or surgery are subjected to irreversible electroporation (IRE). The IRE may be carried out (1) before, (2) at substantially the same time, or (3) just after the procedure (e.g. angioplasty) is carried out, but is carried out before restenosis occurs to obtain the best results. The IRE may be carried out by the use of electrodes which are present on or near the balloon portion of the balloon catheter used in the angioplasty. The IRE is carried out using a voltage and current within defined ranges over a defined period of time. Further, the IRE is carried out in the absence of a drug being delivered to the vascular cells in a manner which would effect the growth of the cells.

[0019]The IRE is not carried out in order to provide for reversible electroporation of substantially all of the cells. Reversible electroporation is carried out when the pores of the cells are temporarily opened and after the procedure go back to normal size and the cells survive. Others carry out electroporation in a manner so as to prevent excessive cell lysing (see U.S. Pat. Nos. 6,865,416 and 6,342,247). With irreversible electroporation the pores of the cells are opened and are opened to a degree that they do not return to normal size and the cells die, so excessive lysing of cells is desired. Thus, irreversible elec...

Problems solved by technology

Notwithstanding the importance of PTA procedures in restoring normal blood flow to an anatomical region, one problem associated with PTA procedures is the undesired re-growth of the lesion, commonly known as re-stenosis.

Although the use of stents has reduced the re-stenosis rate to approximately 30% of the procedures, re-stenosis remains a significant clinical problem, particularly for those patients whose general health is not conducive to repeat interventional procedures.

The main cause of re-stenosis following angioplasty procedures is due to vessel wall trauma created during the procedure.

An overgrowth of endothelial cells triggered by the trauma leads to a re-narrowing of the ve...

Images