Balloon Cage Structure for Controlled Plaque Dissection
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Solution Overview
Problem
Balloon angioplasty procedures face challenges such as unpredictable plaque cleavage, arterial injury, and drug delivery inefficiencies due to plaque heterogeneity and unpredictable balloon expansion, particularly in treating atherosclerotic occlusive disease.
Innovation Solution
A cage is positioned around a medical balloon, comprising first and second rings and a plurality of strips, which can be expanded to control balloon expansion, protect drug coatings, and include spikes for plaque dissection.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a standard balloon is used for angioplasty, then the procedure is simple, but plaque cleavage is unpredictable and arterial injury may occur
Solution Approach 1:
The cage is divided into multiple longitudinal strips that can independently expand and contract. This segmentation allows each strip to interact with the plaque at different locations, providing controlled and predictable plaque disruption while maintaining overall structural integrity. The strips can be made of different materials or have different properties to address heterogeneous plaque composition.
Solution Approach 2:
The cage transitions from a compressed delivery state to an expanded treatment state, dynamically adapting its structure during the procedure. The strips are designed to expand radially when the balloon inflates, transforming from a low-profile configuration suitable for delivery to a high-profile configuration that provides controlled plaque disruption and drug delivery protection.
2Reliability
If the balloon is inflated to treat plaque, then the artery is opened, but dog boning occurs at the balloon ends
Solution Approach 1:
The cage strips provide different levels of support at different locations along the balloon. The strips are designed with specific geometries and material properties that create localized reinforcement at the balloon ends, preventing dog boning while allowing controlled expansion in the middle section where plaque treatment is needed. This local differentiation of structural properties addresses the non-uniform expansion problem.
3Reliability
If the balloon is advanced through the vessel, then delivery is efficient, but drug coating is exposed and diluted prematurely
Solution Approach 1:
The cage structure is nested around the balloon, creating a protective enclosure for the drug-coated balloon during delivery. The strips form a cage-like structure that shields the drug coating from premature exposure to blood flow, preventing dilution and ensuring the drug is delivered only when the cage is expanded at the target site.
Solution Approach 2:
The cage is pre-assembled around the balloon in a compressed state during manufacturing, protecting the drug coating from the moment of coating application through delivery. This preliminary protective action ensures the drug remains intact and concentrated until the moment of deployment, when the cage expands to allow controlled drug release.
4Reliability
If the cage is expanded to protect the drug coating, then drug delivery is controlled, but the cage structure becomes more complex
Solution Approach 1:
The cage structure serves multiple functions simultaneously: it protects the drug coating during delivery, provides controlled plaque disruption through its strips, prevents dog boning, and facilitates uniform balloon expansion. This multi-functionality reduces the need for separate devices or components, managing overall system complexity while achieving multiple therapeutic goals.
Data Source
AI summary
A cage can be positioned around a medical balloon, such as an angioplasty balloon, to assist in a medical procedure. The cage can include a plurality of strips, each extending between a set of rings including first and second rings. As the balloon expands, the first and second rings move closer together and allow the strips to expand outward. The cage may have wedge dissectors on the strips.