Double Wall Catheter Balloon Reservoir Drug Delivery
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Solution Overview
Problem
Existing medical devices with therapeutic coatings face challenges in maintaining and delivering drugs effectively, especially during transient insertion into target tissues, as the coatings can be easily removed or degraded before reaching the intended site, and they lack the capacity to provide a sufficient volume of therapeutic agents.
Innovation Solution
A catheter assembly with an inner and outer expandable balloon structure that retains a therapeutic composition in a reservoir, allowing it to be released only when the device is expanded to the target site, using a lumen for increased capacity and protecting the composition from surroundings until release.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a thin polymeric coating containing therapeutic compounds is used on the device surface, then the drug release can be controlled and protected, but the coating may not be ideal for transient insertion applications as the drug can be easily removed or degraded before reaching the target tissue
Solution Approach 1:
The patent employs a nested structure with an inner balloon containing the therapeutic composition surrounded by an outer balloon. This nested configuration protects the therapeutic coating from degradation during insertion while enabling controlled release at the target site through expansion of the inner balloon.
Solution Approach 2:
The therapeutic composition is pre-applied to the inner balloon surface before insertion, and the device is designed to maintain this coating intact during the insertion process. The outer balloon provides preliminary protection, and only upon reaching the target site and expanding does the controlled release commence.
2Reliability
If a reservoir between inner and outer balloons is used to retain therapeutic composition, then the composition is protected from surroundings and can be delivered effectively, but the device complexity increases
Solution Approach 1:
The inner balloon containing the therapeutic composition is nested within the outer balloon structure. This nested design provides a protected reservoir that maintains the therapeutic coating while enabling controlled release through the expansion mechanism, balancing protection with deliverability.
Solution Approach 2:
The device transitions from a compressed delivery configuration to an expanded treatment configuration. The dynamic expansion of the inner balloon within the outer balloon enables the system to switch between protected retention and controlled release states, managing complexity through state transformation.
3Reliability
If the catheter is in contracted state during insertion, then the openings are closed and therapeutic composition is retained, but the capacity for therapeutic composition may be limited
Solution Approach 1:
The inner balloon expands from a low-profile contracted state during insertion to a high-volume expanded state at the treatment site. This dynamic volume transformation allows the device to maintain reliable retention during transport while providing sufficient therapeutic composition capacity when deployed.
Solution Approach 2:
The therapeutic composition capacity is increased by utilizing the radial dimension through balloon expansion. The inner balloon expands outward between the inner and outer balloons, creating additional volume in the radial direction to accommodate larger quantities of therapeutic composition without increasing the axial insertion profile.
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
Ensures effective delivery of therapeutic agents to the target site by maintaining the composition until expansion, preventing premature release or degradation, and providing a larger volume of treatment, enhancing the efficacy of drug delivery in medical procedures.
Implementation Method 1
Expanding the inner balloon (e.g., with fluid) urges the assembly to its dilated state, in which the openings are open, and the therapeutic composition can leave the assembly
Data Source
AI summary
The present invention relates to a catheter assembly that can deliver a therapeutic composition. The catheter assembly can include an outer balloon with openings for releasing the therapeutic composition. When the catheter assembly is in its contracted state, the openings are closed, and the assembly retains the therapeutic composition. When the catheter assembly is in its dilated state, the openings are open, and the therapeutic composition is released. The present invention also includes methods of making and using such a catheter assembly.