Catheter Balloon Shape Control via Movable Guidewire Lumen
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Solution Overview
Problem
Medical devices with expandable elements, such as balloons, often face issues with improper deflation leading to increased radius and complications during extraction and repositioning, and are limited to specific dimensions suitable for only certain procedures, requiring multiple devices with varying dimensions.
Innovation Solution
A medical device with an elongate body, fluid injection lumen, and a guidewire lumen, featuring an expandable element that can be deflated into its original folded state through a tensioning element and actuator system, allowing for manual control and size detection, enabling the balloon to be easily removed and repositioned and its dimensions modified during use.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the balloon is deflated after inflation, then the balloon can be removed or repositioned, but the balloon may bunch up or improperly deflate causing a larger than desirable radius that complicates extraction and repositioning
Solution Approach 1:
The patent applies dynamics by making the guidewire lumen movable relative to the catheter body, allowing it to shift position in response to balloon inflation and deflation. This movement enables the deflated balloon to return to its original folded configuration rather than bunching up, resolving the shape control issue during removal and repositioning operations.
Solution Approach 2:
The patent changes the physical state and configuration parameters of the guidewire lumen throughout the procedure. During inflation, the guidewire lumen is in a retracted or relaxed state; during deflation, it transitions to a tensioned or extended state that pulls the balloon into its proper folded configuration, thereby controlling the balloon's shape parameter during extraction.
2Reliability
If the balloon is manufactured with fixed dimensions for a specific application, then it provides appropriate size for that procedure, but multiple catheters with varying fixed dimensions are needed for different procedures
Solution Approach 1:
The patent transforms the balloon from a static fixed-dimension component to a dynamic structure whose effective dimensions can be modified during use. The movable guidewire lumen allows the balloon to be tensioned into different configurations, enabling a single catheter to adapt to multiple procedural requirements with varying dimensional needs.
Solution Approach 2:
The patent creates a universal catheter system that can perform multiple functions across different procedures. By enabling the balloon to be tensioned into various configurations, a single catheter design can accommodate multiple procedural requirements that previously would have required multiple specialized catheters with different fixed dimensions.
3Device complexity
If the guidewire lumen is fixed in position, then the structure is simple, but the expandable element cannot be tensioned to control its configuration during deflation
Solution Approach 1:
The patent introduces a movable guidewire lumen that can shift its position along the catheter body. This dynamic positioning capability allows the operator to control the tension applied to the balloon during deflation, enabling precise control of the balloon's configuration without requiring complex additional mechanisms.
Solution Approach 2:
The movable guidewire lumen acts as an intermediary element that transmits tension forces from the operator's manipulation at the proximal end to the balloon at the distal end. This intermediary mechanism provides a simple yet effective way to control balloon configuration during deflation without directly manipulating the balloon itself.
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 the balloon to deflate into its original folded state for easy removal and repositioning, and allows for real-time control of its size and shape during procedures, reducing complications and the need for multiple devices with fixed dimensions.
Implementation Method 1
The tensioning element may provide a biasing force that urges a portion of the guidewire lumen into a particular configuration
Data Source
AI summary
The present invention provides a medical device having an catheter body defining proximal and distal portions, and a guidewire lumen at least partially disposed within and movable within the catheter body. The medical device may include an expandable element defining a proximal end and a distal end, wherein the proximal end is coupled to the distal portion of the catheter body and the distal end is coupled to the guidewire lumen. In addition, an actuator element may be coupled to the guidewire lumen for longitudinal movement thereof, and a tensioning element may further be coupled to the guidewire lumen to bias the guidewire lumen and/or the expandable element towards a particular geometric configuration.