Method and apparatus for treatment of hypertension through percutaneous ultrasound renal denervation
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Publication Number
US-12274833-B2
Publication Date
2025-04-15
Expiration Date
Abstract
Apparatus and methods for deactivating renal nerves extending along a renal artery of a mammalian subject to treat hypertension and related conditions. An ultrasonic transducer (30) is inserted into the renal artery (10) as, for example, by advancing the distal end of a catheter (18) bearing the transducer into the renal artery. The ultrasonic transducer emits unfocused ultrasound so as to heat tissues throughout a relatively large impact volume (11) as, for example, at least about 0.5 cm3 encompassing the renal artery to a temperature sufficient to inactivate nerve conduction but insufficient to cause rapid ablation or necrosis of the tissues. The treatment can be performed without locating or focusing on individual renal nerves.
Core Innovation
The invention relates to inactivating renal nerve conduction in a mammalian subject by inserting an unfocused ultrasound transducer into a renal artery using a catheter. The ultrasound transducer is positioned at a distal portion of the catheter and emits a dose of unfocused ultrasound energy into an impact volume of at least 0.5 cm3, with the impact volume encompassing the renal artery so that the energy is applied at a therapeutic level sufficient to inactivate conduction of renal nerves within the impact volume.
The invention emphasizes applying unfocused ultrasound energy without a need to locate or focus individual renal nerves. It uses a 360° emission geometry within the near-field so that emission encompasses the artery and applies therapeutic energy to renal nerves within the impact volume. This approach is described as maintaining renal artery intima temperatures well below about 65°C while heating renal nerves above about 42°C, thereby avoiding rapid tissue ablation.
An apparatus is described for delivering and controlling the dose, including a balloon for centering and a circulating coolant aqueous liquid to cool the renal artery intima and limit intimal damage. The system includes an ultrasound actuator/control system with an excitation source and control configured to emit the dose, with frequency selection using a reader of machine-readable elements or a frequency scanning approach. A workflow is described that measures artery size using low-power “ping” echo delay, selects acoustic power using a lookup table, and then delivers therapeutic energy, with variations such as pulsed operation and optional skipping of the size measurement.
Claims Coverage
The patent includes two independent claims, a system claim and a method claim. Across these independent claims, there are four main inventive themes: catheter insertion of an unfocused ultrasound transducer into a renal artery, emission into an impact volume of at least 0.5 cm3 encompassing the renal artery, therapeutic-level energy sufficient to inactivate renal nerve conduction within that impact volume, and an expansible structure at the catheter distal portion.
Catheter with distal portion inserted into renal artery
A catheter comprising a distal portion configured to be inserted into the renal artery of the mammalian subject.
Unfocused ultrasound transducer positioned at distal portion
An ultrasound transducer positioned at the distal portion of the catheter, the ultrasound transducer configured to be inserted into the renal artery of the mammalian subject.
Unfocused ultrasound dose applied into impact volume at least 0.5 cm3
An actuator electrically connected to the ultrasound transducer, the actuator configured to cause the ultrasound transducer to emit a dose of unfocused ultrasound energy into an impact volume of at least 0.5 cm3.
Therapeutic level to inactivate renal nerve conduction within impact volume
The impact volume encompasses the renal artery so that the unfocused ultrasound energy is applied at a therapeutic level sufficient to inactivate conduction of renal nerves within the impact volume.
Insert unfocused ultrasound transducer into renal artery along catheter with expansible structure
Inserting an ultrasound transducer into a renal artery of the mammalian subject, wherein the ultrasound transducer is positioned along a distal portion of a catheter, the distal portion of the catheter comprising an expansible structure.
Actuate to emit unfocused ultrasound dose into impact volume at least 0.5 cm3
Actuating the ultrasound transducer, using an actuator electrically connected to the ultrasound transducer, to cause emission of a dose of unfocused ultrasound energy into an impact volume of at least 0.5 cm3.
Therapeutic level to inactivate renal nerve conduction within encompassing impact volume
Wherein the impact volume encompasses the renal artery so that the unfocused ultrasound energy is applied at a therapeutic level sufficient to inactivate conduction of renal nerves within the impact volume.
Both independent claims focus on delivering a dose of unfocused ultrasound energy from a transducer inserted into the renal artery such that the dose is applied into an impact volume of at least 0.5 cm3 encompassing the renal artery, with therapeutic-level emission sufficient to inactivate renal nerve conduction within that impact volume.
Stated Advantages
Provides inactivation of renal nerve conduction without rapid tissue ablation, by maintaining renal artery intima temperatures well below about 65°C while heating renal nerves above about 42°C.
Does not require locating or focusing individual renal nerves, using a 360° emission geometry within the near-field to encompass the artery.
Limits renal artery intimal damage by using a balloon with circulating coolant aqueous liquid.
Documented Applications
Treatment of hypertension by inactivating renal nerve conduction using catheter-based emission of unfocused therapeutic-level ultrasound into an impact volume encompassing a renal artery.
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