Integrated Imaging Drug Eluting Balloon for Vessel Apposition
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Solution Overview
Problem
Current drug eluting balloon (DEB) systems face challenges in accurately positioning and ensuring complete apposition of the drug eluting coating with the treatment area within a vessel, leading to potential inefficiencies in treating vascular diseases.
Innovation Solution
An integrated therapeutic and imaging catheter system that includes a drug eluting balloon assembly with an imaging device, allowing for real-time imaging and adjustment of the balloon's inflation pressure to ensure complete contact of the drug eluting coating with the treatment area, utilizing IVUS, OCT, or other imaging modalities for precise placement and apposition verification.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If drug eluting balloon coatings are used to treat plaque in blood vessels, then therapeutic effect is improved, but placement precision and apposition completeness deteriorate
Solution Approach 1:
The patent combines the drug eluting balloon with an intravascular imaging device (IVUS or OCT) into a single integrated catheter system. This merging allows the imaging device and drug delivery system to be positioned together within the vessel, enabling real-time visualization during drug coating application and ensuring precise placement while maintaining therapeutic effectiveness
Solution Approach 2:
The imaging device provides real-time feedback on the balloon's position and the drug coating's apposition to the vessel wall. This feedback mechanism allows the operator to verify complete coverage of the treatment area and make adjustments if necessary, ensuring manufacturing precision is achieved during the procedure
2Productivity
If drug eluting balloon is inflated to apply coating, then drug delivery effectiveness is improved, but risk of incomplete apposition deteriorates
Solution Approach 1:
The integrated imaging device provides real-time feedback during balloon inflation to monitor the drug coating's apposition to the vessel wall. This allows immediate detection of incomplete coverage and enables corrective actions such as repositioning or re-inflation to ensure complete apposition
Solution Approach 2:
The imaging device is positioned and the treatment area is identified and verified before balloon inflation occurs. This preliminary imaging action ensures the balloon is correctly positioned and allows prediction of potential apposition issues before drug delivery begins
3Manufacturing precision
If multiple imaging and treatment steps are performed, then placement accuracy is improved, but treatment time deteriorates
Solution Approach 1:
By merging the imaging device and drug eluting balloon into a single integrated catheter, the patent eliminates the need for separate positioning and verification steps. The imaging and treatment functions are performed in one continuous procedure, maintaining high placement accuracy while reducing overall treatment time
Solution Approach 2:
The imaging and drug delivery processes are performed continuously in sequence without removing the catheter from the vessel. The balloon is inflated, the drug is applied, and apposition is verified in a continuous workflow, eliminating time losses associated with repeated catheter insertions and withdrawals
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 accurate and effective application of the drug eluting coating by ensuring complete apposition with the vessel wall, enhancing treatment efficacy and reducing the risk of incomplete coating, thereby improving the therapeutic outcome.
Implementation Method 1
The transducers emit ultrasonic waves in order to create an image of the vessel of interest
Implementation Method 2
a catheter carrying both an optical coherence tomography (OCT) lens, from which OCT imaging light is emitted
Implementation Method 3
the DEB assembly is inflated to thereby apply the drug eluting coating to the treatment area
Data Source
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AI summary
An integrated therapeutic and imaging catheter includes an imaging device and drug eluting balloon ("DEB") assembly. The DEB assembly is a balloon assembly having its outer surface coated with a drug eluting coating. In operation, the DEB catheter is inserted into a patient's vessel, whereby the vessel walls are imaged by the imaging device. After identification of a treatment area within the vessel, the DEB assembly is inflated to apply the drug eluting coating to the treatment area. After application, the treatment area and the drug eluting coating may be re-imaged in order to determine if the treatment area was sufficiently coated. If the treatment area is found to be insufficiently coated, the DEB assembly may be re-inflated to thereby sufficiently coat the treatment area.