Balloon Catheter Lumen Sizing for Ultrasound Neuromodulation
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Solution Overview
Problem
Existing methods for treating renal nerves using RF or HIFU technologies face challenges such as incomplete nerve ablation, risk of vessel damage, and exposure to radiation, necessitating improved methods for accurate vessel sizing and neuromodulation.
Innovation Solution
A catheter-based system with an ultrasound transducer and balloon is used to determine vessel size non-invasively, allowing for precise neuromodulation by emitting unfocused ultrasonic energy to treat renal nerves while minimizing vessel damage and radiation exposure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If RF electrodes are used to create electrical field for tissue ablation, then renal nerves can be treated, but the confined electric fields may miss some nerves leading to incomplete treatment and RF electrode contact with intima poses risk of vessel damage
Solution Approach 1:
The patent replaces RF electrical field-based tissue heating with ultrasound-based tissue heating. The ultrasound transducer emits acoustic energy that is converted to thermal energy in the tissue, eliminating the need for RF electrodes to contact the vessel intima and the associated risks of intimal damage, thrombus formation, and fibrosis.
Solution Approach 2:
The patent introduces a balloon as an intermediary medium between the ultrasound transducer and the renal artery. The balloon is inflated to press the transducer against the vessel wall, ensuring proper positioning and acoustic coupling while isolating the transducer from direct contact with blood flow and preventing thermal damage to the intima.
2Manufacturing precision
If HIFU is used to heat renal nerves through vibrational energy, then nerve ablation can be achieved, but the method requires precise focusing which may be difficult to achieve in all vessel sizes
Solution Approach 1:
Instead of using focused ultrasound (HIFU) that requires precise focusing, the patent employs unfocused ultrasound that emits acoustic energy in a broader pattern. This inverted approach sacrifices some precision in exchange for greater adaptability to different vessel sizes and anatomies, while the balloon ensures proper energy delivery to the target tissue.
Solution Approach 2:
The patent changes the ultrasound parameters from focused to unfocused emission, allowing the same device to treat patients with varying renal artery diameters. The balloon adaptation mechanism allows the system to accommodate different vessel sizes by adjusting balloon inflation pressure and transducer positioning rather than requiring precise acoustic focusing for each patient.
3Object-affected harmful factors
If traditional vessel sizing methods are used, then radiation exposure occurs, but non-invasive methods lack precision for accurate neuromodulation dosing
Solution Approach 1:
The system performs self-measurement by using the ultrasound transducer itself to emit acoustic energy and detect the resulting signals for determining vessel dimensions. This eliminates the need for separate imaging procedures that expose patients to radiation, while the direct measurement at the treatment site provides accurate sizing for neuromodulation dosing.
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 system enables accurate vessel sizing and effective neuromodulation, reducing the risk of vessel damage and radiation exposure, and treating conditions like hypertension and diabetes by precisely targeting renal and hepatic nerves.
Implementation Method 1
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 2
Electrical cabling, which is received within a cabling lumen of the catheter, can be used to power the ultrasound transducer. The ultrasound transducer emits one or more therapeutic doses of unfocused ultrasound energy
Implementation Method 3
The system may also include a balloon mounted at the distal end of the catheter used to circulate cooling fluid both prior to, during, and after activation of the transducer to cool the transducer and help prevent thermal damage to the interior surface of the blood vessel wall
Data Source
AI summary
A tissue treatment system and method of using the tissue treatment system determines a size of a body lumen, or a neuromodulation parameter corresponding to the size of the body lumen. The tissue treatment system fills a balloon with a fluid when the balloon is within a body lumen. A fluid parameter of the fluid is detected over a period of time. A parameter curve of the fluid parameter is determined. The parameter curve includes the fluid parameter versus an independent variable over the period of time. The parameter curve includes inflections that correspond to changes in the fluid parameter. Based on the inflections, the system can determine the body lumen size or the neuromodulation parameter. Other embodiments are also described and claimed.