Selectively Insulated Ultrasound Transducers for Conductive Fluids
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Solution Overview
Problem
Existing renal nerve treatment methods using RF and HIFU systems face challenges such as incomplete treatment, risk of vessel damage, and difficulty in aligning focal zones with renal nerves, leading to inefficiencies and potential complications.
Innovation Solution
Development of selectively insulated ultrasound transducers with one electrode covered by an electrical insulator, allowing safe operation within electrically conductive fluids, such as blood or cooling fluids, to prevent electrical shorts and ensure uniform energy delivery for targeted tissue treatment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If both electrodes of the ultrasound transducer are exposed to electrically conductive fluid (blood or cooling fluid), then the transducer can operate in the body lumen, but electrical shorts occur between the electrodes through the conductive fluid
Solution Approach 1:
The patent applies electrical insulation selectively to specific regions of the transducer electrodes rather than uniformly insulating all surfaces. The first electrode is insulated on its outer surface facing the cooling fluid, while the second electrode remains exposed. This localized insulation approach prevents electrical shorts through the conductive cooling fluid while maintaining the functional integrity of the transducer for ultrasound energy delivery.
2Reliability
If non-conductive cooling fluid is used to prevent electrical shorts, then electrical insulation is provided, but the fluid cannot effectively cool the transducer and surrounding tissue
Solution Approach 1:
The patent introduces an electrical insulator as an intermediary layer between the first electrode and the conductive cooling fluid. This insulator layer allows the cooling fluid to maintain electrical conductivity for effective heat removal while preventing direct electrical contact that would cause shorts. The insulator mediates between the conflicting requirements of electrical isolation and thermal conduction.
3Reliability
If RF electrodes are repositioned multiple times around the renal artery to treat all nerves, then complete nerve coverage is achieved, but treatment time increases and vessel damage risk increases
Solution Approach 1:
The ultrasound transducer is designed with segmented electrode structures where the first electrode has an insulated outer surface and the second electrode has an exposed outer surface. This segmentation allows the transducer to deliver focused ultrasound energy to specific angular segments of the renal artery in a single positioned state, treating nerves at specific radial distances without requiring multiple repositioning operations.
4Power
If HIFU creates a thin focal ring, then energy is concentrated, but it is difficult to align with renal nerves at differing radial distances and the longitudinal treatment zone is small
Solution Approach 1:
The patent transitions from the traditional HIFU approach of creating a thin focal ring in three-dimensional space to an unfocused ultrasound approach that creates a broader treatment zone. By eliminating the tight focal concentration and using a larger aperture transducer with selective electrode insulation, the system expands the effective treatment dimension to accommodate nerves at multiple radial distances and longitudinal positions simultaneously.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The solution provides effective and predictable neuromodulation of renal nerves, reducing the risk of vessel damage and ensuring complete treatment zones, enhancing treatment efficacy and safety.
Implementation Method 1
The piezoelectric material is actuated by application of a voltage between the first and second electrodes so as to emit ultrasonic waves
Implementation Method 2
The electrical insulator is configured to inhibit the first electrode from coming into contact with the electrically conductive fluid, and thereby inhibit electrical conduction between the first electrode and the second electrode
Implementation Method 3
The ultrasound transducer emits one or more therapeutic doses of unfocused ultrasound energy, which heats the tissue adjacent to the body lumen within which the transducer is disposed
Implementation Method 4
high-intensity focused ultrasound (HIFU), which relies on vibrational energy to cause frictional heating and disruption of the tissue
Implementation Method 5
a cooling fluid is circulated through the balloon, both prior to, during, and after activation of the transducer, so as to reduce heating of an inner lining of the body lumen
Implementation Method 6
The cooling fluid may act to transfer heat away from the ultrasound transducer and surrounding tissue during use
Data Source
AI summary
Disclosed herein are ultrasound transducers that are selectively insulated to thereby enable the transducers to be exposed to an electrically conductive fluid without causing a short circuit between electrodes of the transducers. Such a transducer includes a piezoelectric transducer body having a first surface and a second surface that are spaced apart from one another and do not intersect with one another. The ultrasound transducer also includes a first electrode disposed on the first surface, a second electrode disposed on the second surface, and an electrical insulator covering only one of first and second electrodes and configured to inhibit electrical conduction between the first electrode and the second electrode when the ultrasound transducer is placed within an electrically conductive fluid. Also disclosed are apparatuses and systems that include such a transducer. Related methods are also disclosed herein.