BALLOON CATHETER METHOD FOR REDUCING RESTENOSIS VIA IRREVERSIBLE ELECTROPORATION
First Claim
1. A method of reducing restenosis, comprising:
- inserting into a vessel of a human patient a balloon catheter comprised of a flexible elongated shaft comprising a distal end portion for insertion into a vessel, wherein the balloon catheter is comprised of;
a balloon positioned at the distal end portion;
a first electrode positioned at the distal end portion of the shaft, the first electrode being comprised of a conductive material which is flexible and generally conforms to an outer surface of the balloon during expansion of the balloon;
a second electrode positioned at a point relative to the first electrode so as to allow electrical current to flow between the electrodes and through vascular tissue to the first electrode, the second electrode being comprised of a conductive material which is flexible and conforms to an outer surface of the balloon during expansion of the balloon; and
providing electrical pulses to the electrodes for durations and in amounts sufficient to subject substantially all vascular cells in a target area of an artery to irreversible electroporation (IRE).
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0 Petitions
Accused Products
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.
297 Citations
20 Claims
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1. A method of reducing restenosis, comprising:
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inserting into a vessel of a human patient a balloon catheter comprised of a flexible elongated shaft comprising a distal end portion for insertion into a vessel, wherein the balloon catheter is comprised of; a balloon positioned at the distal end portion; a first electrode positioned at the distal end portion of the shaft, the first electrode being comprised of a conductive material which is flexible and generally conforms to an outer surface of the balloon during expansion of the balloon; a second electrode positioned at a point relative to the first electrode so as to allow electrical current to flow between the electrodes and through vascular tissue to the first electrode, the second electrode being comprised of a conductive material which is flexible and conforms to an outer surface of the balloon during expansion of the balloon; and providing electrical pulses to the electrodes for durations and in amounts sufficient to subject substantially all vascular cells in a target area of an artery to irreversible electroporation (IRE). - View Dependent Claims (2, 3, 4, 5, 6, 7)
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8. A balloon catheter device for insertion into a vessel and reducing neointima, comprising:
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a flexible elongated shaft comprising a distal end portion for insertion into a vessel; a balloon positioned at the distal end portion; a first electrode positioned at the distal end portion of the shaft, the first electrode being comprised of a conductive material which is flexible and generally conforms to an outer surface of the balloon during expansion of the balloon; a second electrode positioned at a point relative to the first electrode so as to allow electrical current to flow between the electrodes and through vascular tissue to the first electrode, the second electrode being comprised of a conductive material which is flexible and conforms to an outer surface of the balloon during expansion of the balloon; an electrical power source which provides electrical pulses to the electrodes for durations and in amounts sufficient to subject substantially all vascular cells in an area of an artery to irreversible electroporation (IRE) before neointima occurs. - View Dependent Claims (9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20)
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Specification