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Publication Number
US-10967160-B2
Publication Date
2021-04-06
Expiration Date
Abstract
There is provided in accordance with an exemplary embodiment of the invention a method of treating a subject suffering from a nerve related disorder, the method comprising causing a damage region to one or both of a lumen wall or nearby surrounding tissues, the damage region encompassing a volume having dimensions of less than about 6.8 mm in a substantially radial direction, less than about 5.8 mm in a direction substantially tangential to the lumen, less than about 10 mm in a substantially axial direction, the damage region being located no closer than about 0.2 mm from an inner wall of the lumen, the damage region comprises of greater than about 60% of collagen denatured tissue.
Core Innovation
The invention is a method of treating a subject suffering from a nerve related disorder by selecting a thermal effect on nerve tissue within a damage region that comprises one or both of a lumen wall or nearby surrounding tissues. The method selects parameters of unfocused ultrasound to achieve the thermal effect, including an intensity between 10 Watt/cm2 and 35 Watt/cm2, a frequency between 10 Mhz and 20 Mhz, and a treatment duration between 10 and 30 seconds. The method selects a size of an acoustic element configured to emit the unfocused ultrasound with a width between 0.2 mm and 2 mm and a length between 1 mm and 10 mm.
The method irradiates, from within a lumen, the damage region with unfocused ultrasound so that blood flow cools the wall enough to allow the damage region to be located no closer than 0.2 mm from the inner wall, while preventing damage to the inner wall. The irradiating is performed at a distance of at least 1 mm from the inner wall, and the damage region encompasses a volume with dimensions within specified ranges in radial, tangential, and axial directions. The damage region is located between 0.2 mm and 10 mm from an inner wall of the lumen.
The lumen is a lumen of a blood vessel with blood flowing therein. The damage region is defined to include a thermal effect on nerve tissue in and/or near the lumen wall, while using blood-flow cooling to position the thermal damage region away from the inner wall and to protect the inner wall. In the disclosed context, the approach is applied to nerve-related disorders, including hypertension, and is described as enabling selective thermal injury in peri-adventitia/adventitia/media while avoiding the intima and limiting stenosis or constriction.
Claims Coverage
The partial content identifies two independent claims that cover delivering unfocused ultrasound from within a blood vessel lumen to create a thermal effect in a defined damage region on nerve tissue, with explicit quantitative bounds for ultrasound parameters, acoustic element geometry, and damage-region dimensions, and with delivery at a distance that enables blood-flow cooling to protect the inner wall. Across the independent claims, the inventive coverage includes 3 core parameter groups (ultrasound parameter selection, acoustic element size selection, and damage-region dimensional selection) plus a delivery-distance requirement tied to protecting the inner wall.
Lumen-delivered unfocused ultrasound with selected thermal effect region
A method selecting a thermal effect on nerve tissue within a damage region comprising one or both of a lumen wall or nearby surrounding tissues, and selecting parameters of unfocused ultrasound to be irradiated to achieve said thermal effect.
Unfocused ultrasound parameter ranges for nerve tissue thermal effect
The parameters comprise an intensity between 10 Watt/cm2 and 35 Watt/cm2, a frequency between 10 Mhz and 20 Mhz, and a treatment duration between 10 and 30 seconds.
Acoustic element size selection for unfocused ultrasound emission
Selecting a size of an acoustic element configured to emit said unfocused ultrasound, said acoustic element having a width between 0.2 mm and 2 mm and a length between 1 mm and 10 mm.
Damage-region geometry and separation from inner wall using blood-flow cooling
Irradiating, from within said lumen, said region with unfocused ultrasound, said irradiating performed at a distance of at least 1 mm from said inner wall so that blood flow cools said wall enough to allow said damage region to be located no closer than 0.2 mm from said inner wall, and to prevent damage to said inner wall; said damage region encompassing a volume having dimensions ranging between 0.2-6.8 mm in a radial direction, between 0.2-5.75 mm in a direction tangential to said lumen, between 0.1 mm and 10 mm in an axial direction; said region being located between 0.2 mm and 10 mm from an inner wall of said lumen.
Blood-vessel lumen with blood flowing during irradiation
Wherein said lumen is a lumen of a blood vessel with blood flowing therein.
The independent claims broadly cover creating a controlled thermal effect on nerve tissue using unfocused ultrasound delivered from within a blood vessel lumen. Coverage is defined by quantitative ultrasound and acoustic element ranges, damage-region dimensional bounds (radial, tangential, axial), and a delivery-distance requirement that uses blood-flow cooling to keep the damage region at least 0.2 mm from the inner wall while preventing inner-wall damage.
Stated Advantages
Prevent damage to the inner wall.
Allow the damage region to be located no closer than 0.2 mm from the inner wall.
Using blood flow cooling to position the thermal damage region away from the inner wall.
Documented Applications
Treating a subject suffering from a nerve related disorder, including hypertension.
Renal denervation context with reduced kidney norepinephrine levels at 30 days [as described in the partial content].
Delivering unfocused ultrasound into a blood-vessel lumen for selective nerve-related thermal effects described as confined to peri-adventitia/adventitia/media while avoiding the intima [as described in the partial content].
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