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Publication Number
US-11730506-B2
Publication Date
2023-08-22
Expiration Date
Abstract
According to some embodiments there is provided a method for controlling a treatment effect on blood vessel tissue during an ultrasonic treatment, the method comprising positioning an ultrasonic transducer device in the blood vessel lumen; controlling a treatment effect by controlling fluid flow, wherein controlling comprises deploying a fluid restrictor at a location relative to the transducer effective to block at least a portion of fluid flowing upstream, downstream or adjacent the transducer. According to some embodiments there is provided an ultrasonic transducer device sized for placement in a body lumen, and comprising a fluid restrictor effective to block at least a portion of fluid flowing upstream, downstream or adjacent the transducer. In some embodiments, the fluid is blood.
Core Innovation
The invention provides a method for selective treatment of nerve fibers covered by fat tissue by introducing a catheter comprising an ultrasound transducer into a blood vessel lumen and positioning the transducer at a distance from the lumen wall. The method selectively damages the nerve fibers over said fat tissue by emitting unfocused ultrasound energy absorbed by the nerve fibers. The unfocused ultrasound has a frequency and an intensity suitable to thermally damage the nerve fibers, and the emitting duration deposits heat in the nerve fibers while allowing the fat tissue to insulate the deposited heat.
The disclosed approach supports selectivity by using conditions that enable thermal deposition in nerve fibers while fat tissue provides insulation. In the context provided, selectivity is driven by blood flow cooling and differing ultrasound attenuation or insulation associated with fat tissue, supporting a thermal treatment in which damage is focused on target nerve regions over fat coverage. The patent document also describes use cases in blood vessel lumen targeting, including nerve-related outcomes such as nerve degeneration and selective thermal injury patterns.
The document further describes an ultrasonic catheter/transducer system that enables in-vessel sensing and treatment with a single transducer using differently damped regions. The system concept includes emitting high-power bursts for heating/ablation while transmitting lower-power sensing/imaging signals for monitoring, including detecting reflected signals and backscatter changes. It also describes online testing or monitoring of transducer performance using impulse response and/or impedance and resonance/anti-resonance monitoring, and it reports experimental histology results indicating thermal damage in vessel wall layers while intima damage is minimal or absent.
Claims Coverage
The provided independent claims are directed to a method for selective treatment and a catheter device configured for such selective treatment, with the independent claim set emphasizing positioning at a distance from the lumen wall and unfocused ultrasound thermal deposition insulated by fat tissue. The inventive features are reflected through multiple inventive feature themes across the independent claims.
Selective nerve-fiber thermal treatment insulated by fat
Emitting unfocused ultrasound energy having a frequency and an intensity suitable to thermally damage nerve fibers over fat tissue, with a duration long enough to deposit heat in the nerve fibers while allowing the fat tissue to insulate the deposited heat.
Catheter positioning at a distance from the lumen wall
Introducing a catheter comprising an ultrasound transducer into a blood vessel lumen and positioning said catheter within said lumen such that said ultrasound transducer is positioned at a distance from the lumen wall.
Unfocused ultrasound energy for selective damaging of nerve fibers
Controlling emission of unfocused ultrasound energy having stored energy parameters including frequency, intensity, and duration to thermally damage nerve fibers over said fat tissue.
Control unit configured to emit stored energy parameters
A control unit comprising a processor and memory storing energy parameters including frequency, intensity, and duration, configured to control emission of unfocused ultrasound energy by the transducer to selectively damage nerve fibers over fat tissue.
Device for selective nerve-fiber treatment using an ultrasound transducer at a distal tip
An ultrasound transducer positioned on a distal tip of said catheter, used to selectively damage nerve fibers covered by fat tissue.
Overall, the independent claims cover selective treatment of nerve fibers covered by fat tissue using unfocused ultrasound thermal deposition, implemented by introducing and positioning the catheter transducer at a distance from the lumen wall and by using a catheter device with a distal transducer and a control unit that emits unfocused ultrasound using stored frequency, intensity, and duration parameters to achieve selective nerve-fiber damage insulated by fat tissue.
Stated Advantages
Selective damaging of nerve fibers covered by fat tissue while fat tissue insulates deposited heat.
Thermal damage deposition in nerve fibers using unfocused ultrasound with a duration sufficient to deposit heat while allowing insulation by fat tissue.
Monitoring of thermal damage by detecting changes in reflected ultrasound signals or changes in backscatter.
Transducer performance can be tested or monitored online using impulse response and/or impedance and resonance/anti-resonance monitoring.
Documented Applications
Selective treatment of nerve fibers covered by fat tissue within a blood vessel lumen, including nerve-related outcomes such as nerve degeneration and examples such as carotid sympathetic nerve.
In-vessel sensing combined with tissue ablation/heating using a single transducer with differently damped regions, with concurrent monitoring using reflected signals and backscatter.
Ultrasonic treatment targeting vessel wall thermal damage patterns supported by histology results, including selective damage in adventitia/media regions with minimal or absent intima damage, as described for pig carotid artery and pig renal artery examples.
Blood-flow-related selectivity and selectivity effects based on tissue composition, including fat tissue insulation and blood flow cooling, for targeted nerve-fiber treatment in vessels.
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