Device and method for electroporation based treatment of stenosis of a tubular body part

Abstract

The present invention relates to medical devices and methods for treating a lesion such as a vascular stenosis using non-thermal irreversible electroporation (NTIRE). Embodiments of the present invention provide a balloon catheter type NTIRE device for treating a target lesion comprising a plurality of electrodes positioned along the balloon that are electrically independent from each other so as to be individually selectable in order to more precisely treat an asymmetrical lesion in which the lesion extends only partially around the vessel.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application is a Continuation application of U.S. patent application Ser. No. 13 / 550,307, filed Jul. 16, 2012, which relies on the disclosure of and claims priority to and the benefit of the filing date of U.S. Provisional Application No. 61 / 508,251, filed Jul. 15, 2011. The disclosures of which are hereby incorporated by reference herein in their entireties.BACKGROUND OF THE INVENTIONField of the Invention[0002]The present invention relates to medical devices and methods for treating, reducing, or preventing stenosis using non-thermal irreversible electroporation. Embodiments of the present invention provide balloon catheter devices for treating or preventing stenosis comprising a plurality of electrodes for selectively and irreversibly electroporating a portion of the inner circumference of a tubular structure within the body. Such devices, systems and methods are particularly useful for treating asymmetrical stenosis.Description o...

AI Technical Summary

Benefits of technology

This patent describes a way to treat a blockage in a blood vessel by using electricity to kill cells in the blockage. The treatment involves using multiple electrodes that can be controlled independently. By selectively using certain electrodes, less power is needed and the treatment can be more targeted, minimizing damage to healthy tissue. Overall, this technology allows for a safer and more effective procedure for treating blood vessel blockages.

Problems solved by technology

The introductions of balloon angioplasty and stent implantation in the coronary arteries have reduced significantly the fatalities associated with this disease, however, coronary artery restenosis and neointimal hyperplasia remain clinical problems.

Although PTA treatments find success in restoring blood flow, such success may be limited or temporary under certain circumstances.

A second angioplasty procedure or bypass are common treatments for restenosis, but each of these exposes the patient to additional risks.

This is because the angioplasty procedure is often a temporary fix as it will retraumatize the vessel wall—resulting in the recurrence of smooth muscle cell proliferation.

It has been found that eccentric and polypoid narrowings are not amenable to treatment with PTA alone.

These efforts, however, have not proven any greater success over conventional angioplasty techniques in preventing restenosis after surgery.

These techniques have been known to reduce restenosis but are not preferred due to complications, such as localized blood clots after elution of the drug, stent fracture, or other long-term implant issues.

Most notable risk factors with stents concern the arterial wall injury that is generated with the implantation of the stent and the pressure applied by the balloon.

In-stent restenosis after bare-metal stent (BMS) placement results in an aggressive healing response (neointimal hyperplasia) that causes vascular narrowing.

These pulses permanently destabilize the cell membranes of the treated tissue and cause cell death.

Unfortunately, this electrode design is highly invasive and requires the physical exposure of the targeted vessel in order to treat it.

Such an approach is not desirable for cases of asymmetrical restenosis, however, where only a portion or less than the entire circumference of the vessel wall is diseased.

In treating asymmetric restenosis with circumferential IRE, vascular cells on non-diseased portions of the vessel wall are unnecessarily destroyed.

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