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

VSEngineering Contradiction Analysis

1Productivity

If high-intensity focused ultrasound is applied to treat clots, then thrombolysis is enhanced, but bleeding outside the target area occurs

Engineering Contradiction:
Improvethrombolysis enhancementVSAvoidbleeding outside target area
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

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.

Inventive Principle:
Principle #23Feedback

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.

Inventive Principle:
Principle #3Local quality

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

Engineering Contradiction:
Improvefocal zone cross-sectionVSAvoidphased-array control system
Core Design Contradiction:
Area of stationary objectVSDevice complexity

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.

Inventive Principle:
Principle #6Universality (Multi-functionality)

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.

Inventive Principle:
Principle #25Self-service

3Manufacturing precision

If real-time monitoring and automated control are implemented, then treatment precision is improved, but system complexity increases

Engineering Contradiction:
Improvetreatment precisionVSAvoidmonitoring and control system
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

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.

Inventive Principle:
Principle #5Merging (Combining)

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

Methodology Applied
Scientific EffectFocused ultrasound: Ultrasound

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

Methodology Applied
Scientific EffectAcoustic energy focusing: Focusing

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

Methodology Applied
Scientific EffectThermal heating: Heating

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

Methodology Applied
Scientific EffectPiezoelectric effect: Piezoelectric Effect

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

Methodology Applied
Scientific EffectImage analysis for liquid content detection: Image Processing

Data Source

PatentEP2358437B1Closed-loop clot lysis
Publication Date: 2018.11.07 INSIGHTEC
  • EP2358437B1 patent drawingFigure 1
  • EP2358437B1 patent drawingFigure 2

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.