Enhanced Methods for Preparing Phospholipid-Based Ultrasound Contrast Agents with Improved Stability
Legal Citation
Summary of the Inventive Concept
This inventive concept introduces novel methods and systems for preparing phospholipid-based ultrasound contrast agents with enhanced stability, by reducing divalent metal cation concentrations and introducing chelating agents, resulting in improved imaging quality and reduced artifacts.
Background and Problem Solved
The original patent disclosed methods for preparing phospholipid-based ultrasound contrast agents, but it was limited by the susceptibility of certain phospholipid-based formulations to divalent metal cations, which can affect the stability and efficacy of the contrast agents. This inventive concept addresses these limitations by introducing novel methods and systems to mitigate the impact of divalent metal cations.
Detailed Description of the Inventive Concept
The inventive concept comprises a system for preparing phospholipid-based ultrasound contrast agents, which includes a calcium-removing module to reduce the concentration of divalent metal cations in a phospholipid solution, and a microsphere-forming module to encapsulate gas microspheres with the phospholipid solution. Additionally, the inventive concept introduces a method for enhancing the stability of lipid-encapsulated gas microspheres by introducing a chelating agent to a phospholipid solution to bind divalent metal cations, and then forming microspheres with the phospholipid solution. The inventive concept also includes a lipid-encapsulated gas microsphere composition with a reduced concentration of divalent metal cations, and a system for real-time monitoring of divalent metal cation concentrations in a phospholipid solution.
Novelty and Inventive Step
The new claims introduce novel and non-obvious solutions to the problem of divalent metal cation susceptibility in phospholipid-based ultrasound contrast agents. The use of calcium-removing modules, chelating agents, and real-time monitoring systems to mitigate the impact of divalent metal cations is a significant departure from the original patent and provides a substantial improvement in the stability and efficacy of the contrast agents.
Alternative Embodiments and Variations
Alternative embodiments of the inventive concept could include the use of different types of chelating agents, varying concentrations of divalent metal cations, and different methods for removing calcium and magnesium ions from the phospholipid solution. Additionally, the inventive concept could be adapted for use with different types of ultrasound contrast agents, such as those based on liposomes or nanoparticles.
Potential Commercial Applications and Market
The inventive concept has significant commercial potential in the medical imaging industry, particularly in the field of ultrasound imaging. The improved stability and efficacy of the contrast agents could lead to better image quality, reduced artifacts, and improved patient outcomes. The target market for this inventive concept includes medical imaging companies, hospitals, and research institutions.
CPC Classifications
| Section | Class | Group |
|---|---|---|
| A | A61 | A61K49/223 |
| A | A61 | A61B8/481 |
| A | A61 | A61K49/226 |
| A | A61 | A61K49/227 |
| C | C07 | C07F9/09 |
| C | C07 | C07F9/106 |
Section 103 Obviousness Analysis (PHOSITA)
Field of Art
Biomedical engineering and pharmaceutical formulation, specifically ultrasound contrast agent preparation, involving expertise in lipid chemistry, microsphere encapsulation techniques, and analytical methods for pharmaceutical composition characterization
Person of Ordinary Skill (PHOSITA) Profile
A researcher or engineer with advanced degrees in chemical engineering, pharmaceutical sciences, or biomedical engineering, possessing knowledge of lipid formulation, microsphere preparation techniques, and understanding of metal ion interactions with phospholipid systems
Obviousness Rationale
A PHOSITA would recognize that managing divalent metal cation concentrations is a predictable engineering challenge in phospholipid-based microsphere preparation. The PTD's proposed solutions of using chelating agents, calcium-removing modules, and real-time monitoring represent straightforward extensions of the source patent's recognition of metal ion susceptibility. These variations apply standard chemical engineering techniques to address the inherent stability challenges identified in the original patent disclosure.
Obvious Combinations & Variations
Original Patent Information
| Patent Number | US 11,857,646 |
|---|---|
| Title | Methods for making ultrasound contrast agents |
| Assignee(s) | Lantheus Medical Imaging, Inc. |