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Publication Number

US-12539160-B2

Patent

Publication Date

2026-02-03

Expiration Date


Abstract

There is provided in accordance with an exemplary embodiment of the invention a method and/or a device of treating tissue near a first lumen comprising inserting an energy emission element into a second lumen and delivering energy in an amount sufficient to cause one or more spaced apart areas of tissue damage at preselected locations in tissue near the first lumen. There is also provided a method and/or a device for treating a carotid artery wall, for example, to reduce signal conduction. There is also provided a method and/or a device for treating a wall of a lumen in a limb, for example, to increase blood flow. There is also provided a method and/or a device for treating a wall of a heart, for example, to stop abnormal signal propagation.

Core Innovation

The invention provides a method of treating nerve tissue by inserting a catheter including an ultrasound emission element into a lumen of a blood vessel having a wall with plaque or calcification. The catheter is positioned at one or more spaced apart locations along the blood vessel lumen where the plaque or the calcification exist, with knowledge that the plaque or the calcification exist at the selected spaced apart locations.

Unfocused ultrasound energy is selectively applied in the form of one or more pencil beams from within the blood vessel lumen and through the plaque or calcification. The selectively applied unfocused ultrasound energy forms one or more spaced apart regions of thermal damage in the nerve tissue located outside the blood vessel lumen, without causing rupture of the plaque or calcification, until the one or more spaced apart regions of thermal damage is obtained.

The disclosed system concepts include a catheter with an ultrasound emission element and a controller, along with imaging and feedback modules, and lumen support or expanding distancing devices that create clearance for cooling. The disclosed examples specifically reference catheter-based unfocused ultrasound applied as pencil beams to treat vessel walls and nerve/perivascular tissue while preserving the first-lumen inner layer.

Claims Coverage

The independent claim covers a method for treating nerve tissue using catheter-delivered unfocused ultrasound in pencil beams, selectively targeted through plaque or calcification at spaced apart locations, while continuing without rupturing the plaque or calcification until spaced regions of thermal damage in nerve tissue outside the vessel lumen are obtained. The inventive features are refined by dependent claims that add quantitative ultrasound parameters, target depths, plaque/calcification presence determination, catheter/emitter structure, and positioning-related constraints.

Targeted catheter positioning through plaque or calcification

Selecting one or more spaced apart locations along said blood vessel lumen where plaque or the calcification exist, wherein said positioning comprises selecting said one or more spaced apart locations with knowledge that the plaque or the calcification exist thereat.

Unfocused ultrasound delivered as one or more pencil beams

Selectively applying unfocused ultrasound energy in a form of one or more pencil beams from within said blood vessel lumen and through said plaque or calcification.

Spaced thermal damage in nerve tissue outside the vessel lumen

Forming one or more spaced apart regions of thermal damage in the nerve tissue located outside said blood vessel lumen by said unfocused ultrasound energy in the form of the one or more pencil beams.

Continue application without causing rupture of plaque or calcification

Continuing said applying, without causing rupture of said plaque or calcification, until said one or more spaced apart regions of thermal damage is obtained.

Unfocused pencil-beam ultrasound intensity range

Applying unfocused ultrasound energy having an intensity between 20 and 50 W/cm^2.

Unfocused pencil-beam ultrasound frequency range

Applying unfocused ultrasound energy having a frequency between 10 MHz and 40 MHz.

Thermal damage depth from the intima

Forming one or more spaced apart regions of thermal damage at about 0.5 mm to 10 mm from the intima of a blood vessel lumen.

Determining plaque or calcification presence

Determining whether plaque or calcification is present in a blood vessel before inserting or positioning a device.

Ultrasound emission element with planar emitting surface

Configuring the ultrasound emission element with a planar emitting surface to emit one or more unfocused pencil beams of unfocused ultrasound energy.

Across the independent claim and refinements, the core claimed approach is catheter-based delivery of unfocused ultrasound as pencil beams from within a blood vessel lumen, targeted at spaced locations where plaque or calcification exist, to create spaced regions of thermal damage in nerve tissue outside the lumen while continuing without rupturing the plaque or calcification. Dependent claims further narrow ultrasound frequency and intensity ranges, specify thermal damage depth relative to the intima, add plaque/calcification presence determination, and require an ultrasound emission element with a planar emitting surface.

Stated Advantages

Creates spaced regions of thermal damage in nerve tissue located outside the blood vessel lumen.

Does not cause rupture of the plaque or calcification while forming the spaced regions of thermal damage.

Documented Applications

Carotid sinus/nerve denervation to reduce signal propagation.

Limb (femoral) vessel denervation across plaque or calcification to increase blood flow.

Treatment of lumen walls using deployed stents, including delivery of energy across or through stent struts without damaging the intima.

Heart denervation involving pulmonary vein ostia and left atrium to disrupt conduction while cooling the endocardium.

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