Enhanced Electrochemical Impedance Spectroscopy for Advanced Tissue Characterization
Legal Citation
Summary of the Inventive Concept
This inventive concept enhances electrochemical impedance spectroscopy (EIS) for advanced tissue characterization, improving the accuracy and efficiency of plaque rupture prediction and atherosclerotic lesion identification.
Background and Problem Solved
The original patent for electrochemical impedance spectroscopy (EIS) has limitations in accurately characterizing tissues and predicting plaque rupture. The new inventive concept addresses these limitations by integrating temperature sensors, operating at multiple frequencies, and combining EIS with ultrasound imaging and fluorescent dye highlighting.
Detailed Description of the Inventive Concept
The new inventive concept comprises a tissue sensing device with a first catheter and a second catheter, each with a lumen, and at least one ultrasound transducer positioned within the first catheter lumen. The device is enhanced with a temperature sensor integrated into the first catheter to monitor tissue temperature during sensing. The EIS sensors operate at multiple frequencies to provide enhanced tissue characterization. The system combines EIS data with ultrasound images to determine the level of oxidized low-density lipoprotein (oxLDL) and macrophage/foam cells present in an atheroma. The device can also identify metabolically active atherosclerotic lesions that are angiographically invisible using a fluorescent dye.
Novelty and Inventive Step
The new claims introduce the integration of temperature sensors, multi-frequency EIS operation, and the combination of EIS with ultrasound imaging and fluorescent dye highlighting, which are not present in the original patent. These enhancements provide a non-obvious solution to the limitations of the original patent.
Alternative Embodiments and Variations
Alternative embodiments may include varying the configuration of the catheters, using different types of sensors, or incorporating additional imaging modalities. Variations may also include adapting the device for use in different medical applications, such as cancer diagnosis or neural tissue characterization.
Potential Commercial Applications and Market
The enhanced EIS technology has significant commercial potential in the medical device industry, particularly in the areas of cardiovascular disease diagnosis and treatment. The market for this technology is substantial, with an estimated value of over $1 billion by 2025.
Section 103 Obviousness Analysis (PHOSITA)
Field of Art
Biomedical engineering, specifically medical diagnostic devices for cardiovascular tissue characterization, focusing on interventional catheter-based sensing technologies
Person of Ordinary Skill (PHOSITA) Profile
A biomedical engineer or medical device researcher with expertise in catheter design, electrochemical sensing, ultrasound imaging, and advanced diagnostic techniques for vascular pathology
Obviousness Rationale
A PHOSITA would recognize that the PTD's variations represent predictable extensions of the source patent's core catheter-based tissue sensing technology. The additional sensing modalities and integration of temperature, multi-frequency EIS, and fluorescent dye highlighting are logical incremental improvements to enhance diagnostic capabilities. These modifications represent standard engineering approaches to improving medical diagnostic devices by combining known sensing techniques to provide more comprehensive tissue characterization.
Obvious Combinations & Variations
Original Patent Information
| Patent Number | US 11,857,318 |
|---|---|
| Title | Electrochemical impedance spectroscopy |
| Assignee(s) | The Regents of the University of California |