HIFU Tissue Biomarker Release for Liquid Biopsy
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Solution Overview
Problem
Current biopsy methods for diagnosing tissue masses, such as prostate cancer, are invasive and prone to missing mutations, and the detection of cancer biomarkers like miRNAs and ctDNA is limited by their low abundance in circulation, necessitating a more effective and less invasive approach.
Innovation Solution
The use of high intensity focused ultrasound (HIFU) energy to selectively induce the release of biomarkers from tissue masses into a fluid, such as blood, allowing for non-invasive or minimally invasive detection and characterization of tissue masses through the analysis of marker concentrations.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If needle biopsy is used to obtain tissue samples, then diagnostic information can be obtained, but the procedure is invasive and carries infection risks
Solution Approach 1:
The patent replaces the mechanical needle biopsy system with an acoustic wave system. High-intensity focused ultrasound (HIFU) waves are used to remotely disrupt tissue and release biomarkers into circulation, eliminating the need for physical needle insertion and thereby removing the associated infection risks while maintaining diagnostic capability through liquid biopsy detection
2Measurement precision
If needle biopsy is performed to obtain tissue samples, then molecular information can be obtained, but mutations may be missed due to sampling limitations
Solution Approach 1:
The patent extracts biomarkers directly from the tissue mass into the bloodstream using HIFU energy, rather than physically removing tissue samples. This allows for the release and detection of molecular information (DNA, RNA, proteins) that would otherwise remain trapped in the tissue, preventing information loss and enabling comprehensive molecular analysis without sampling limitations
Solution Approach 2:
The patent uses the bloodstream as an intermediary medium to transport biomarkers from the tissue mass to detection systems. HIFU energy acts as a mediator to release biomarkers into circulation, allowing molecular information to be accessed through blood draws rather than direct tissue sampling, thereby improving mutation detection accuracy
3Ease of operation
If liquid biopsy is used to detect circulating biomarkers, then non-invasive detection is achieved, but biomarker abundance is too low for reliable detection
Solution Approach 1:
The patent applies HIFU energy to the tissue mass before biomarker detection to preliminarily disrupt the tissue and release biomarkers into circulation. This preliminary action increases biomarker abundance in the bloodstream, ensuring sufficient concentration for reliable detection while maintaining the non-invasive liquid biopsy approach
Solution Approach 2:
The patent uses HIFU energy to change the physical state and release characteristics of biomarkers from the tissue mass. By applying controlled acoustic energy, the system alters the extraction efficiency parameter, significantly increasing biomarker concentration in circulation from undetectable levels to detectable levels, thereby resolving the quantity issue while preserving non-invasive detection
4Productivity
If repeated biopsies are performed to assess tissue mass response, then treatment effectiveness can be monitored, but cumulative infection risk increases
Solution Approach 1:
The patent replaces repeated mechanical needle biopsies with repeated liquid biopsy procedures using HIFU-mediated biomarker release. This substitution allows for frequent monitoring of treatment response through blood draws, which carry no infection risk, thereby enabling high assessment frequency without cumulative infection risk
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
HIFU energy effectively increases the concentration of tumor-specific miRNAs in circulation, enabling rapid and repeated assessment of tissue masses without the risks associated with traditional biopsies, facilitating more informed treatment decisions.
Implementation Method 1
High intensity focused ultrasound (HIFU) energy to selectively induce release of a marker from a tissue mass
Implementation Method 2
high intensity focused ultrasound (HIFU) energy to selectively induce release of a marker from a tissue mass
Data Source
AI summary
The present disclosure is directed to relates to systems and methods for evaluating tissue using high intensity focused ultrasound (HIFU) energy. In one embodiment, for example, a system for treating a patient comprises an ultrasound source configured to deliver HIFU energy to a target tissue mass of the patient and a function generator operably coupled to the ultrasound source for initiating a pulsing protocol for delivering the HIFU energy. The system further comprises a controller configured to perform operations comprising applying HIFU energy to induce cavitation in the target tissue mass and cause a biomarker to be released, comparing a baseline concentration of the biomarker from a first fluid sample to a concentration of the biomarker in a second fluid sample within 2 hours after applying HIFU, and repeating the applying and comparing until the concentration of the biomarker in the fluid sample falls below a threshold value.