Closed-loop Clot Lysis via Phased-array Ultrasound
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Solution Overview
Problem
Current methods for treating thrombotic disease using focused ultrasound are ineffective due to adverse events associated with bleeding outside the target area, necessitating a system that can non-invasively and accurately focus acoustic energy on clots without damaging surrounding tissue.
Innovation Solution
A closed-loop system utilizing a phased-array transducer, imager, and processor to monitor blood flow and clot liquefaction, adjusting ultrasound energy parameters in real-time to ensure precise clot lysis while sparing adjacent tissue, with automated or manual control options.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If high-intensity focused ultrasound is applied to treat clots, then thrombolysis is enhanced, but bleeding outside the target area occurs
Solution Approach 1:
The patent implements a closed-loop control system that continuously monitors treatment parameters and adjusts ultrasound delivery in real-time. Blood flow measurements and treatment response data are fed back to the control system, which modifies subsequent ultrasound pulses to maintain therapeutic effect while preventing adverse events. This feedback mechanism allows dynamic optimization of the treatment zone to avoid bleeding outside the target area.
Solution Approach 2:
The system applies ultrasound energy with highly localized precision to the clot site only. By using focused ultrasound beams and phased array transducers, the treatment is confined to the specific anatomical location of the clot, ensuring that adjacent healthy tissues and distant vessels are not exposed to harmful energy levels. This local quality approach enhances thrombolysis at the target while preventing systemic bleeding complications.
2Area of stationary object
If ultrasound energy is focused on a small target, then surrounding healthy tissue is spared, but precise focusing requires complex phased-array control
Solution Approach 1:
The control system integrates multiple functions into a single unified platform: it performs real-time blood flow monitoring, processes imaging data, calculates optimal focusing parameters, and controls the phased-array transducer elements. This multi-functional integration reduces the need for separate specialized devices and simplifies the overall system architecture while maintaining precise focusing capability on small targets.
Solution Approach 2:
The system incorporates automated algorithms that self-adjust the phased-array control parameters based on real-time feedback from blood flow measurements and imaging data. The control system automatically optimizes focal positioning, beam shaping, and energy distribution without requiring manual intervention, thereby reducing operational complexity while achieving precise focusing on small target areas.
3Manufacturing precision
If real-time monitoring and automated control are implemented, then treatment precision is improved, but system complexity increases
Solution Approach 1:
The patent combines real-time blood flow monitoring, imaging acquisition, treatment planning, and ultrasound delivery control into an integrated system architecture. By merging these previously separate functions into a unified platform with shared hardware and software resources, the system achieves high treatment precision while minimizing the complexity increase that would result from having separate independent systems for each function.
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
Enables non-invasive, timely treatment of clots by accurately focusing acoustic energy, minimizing damage to surrounding tissue and reducing adverse events, effectively treating stroke and other clot-related conditions.
Implementation Method 1
High-intensity focused ultrasound (HIFU) has been shown to enhance thrombolysis induced by tissue plasminogen activator (tPA) in-vitro and in-vivo
Implementation Method 2
ultrasonic energy, in particular, may be focused toward focal zones having a cross-section of only a few millimeters due to relatively short wavelengths
Implementation Method 3
At the focal zone, sufficient acoustic energy may be delivered either to heat tissue until necrosis occurs, or mechanically disrupt its structure until the tissue is destroyed
Implementation Method 4
drive signals are sent to a piezoelectric transducer having a number of transducer elements such that constructive interference occurs at a focal zone
Implementation Method 5
the processor is for (i) automatically analyzing images using image-analysis software configured to recognize fluid flow through or liquid content of the clot and estimating liquid content of the clot
Data Source
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AI summary
The present invention provides procedures and systems that use a closed-loop approach for directing ultrasound energy at a clot while monitoring blood flow and/or liquification of the clot tissue so as to allow automated and/or manual adjustments to various treatment parameters.