Balloon Catheter Stiffening Element Segmentation
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Solution Overview
Problem
Balloon catheters used for intermittent occlusion of the coronary sinus face challenges in maintaining position due to blood pressure counter-force, requiring a balance between rigidity to prevent slippage and flexibility to navigate curved vessel regions, and existing solutions do not adequately address the complexity of precise placement and pressure monitoring.
Innovation Solution
A balloon catheter design featuring a stiffening element with a reduced flexural strength distal end portion, a central pressure sensor lumen, and a balloon pressure-monitoring lumen, allowing for precise pressure measurement and flexible navigation, while maintaining the balloon's position and preventing buckling, with a hypotube providing variable flexibility and a catheter tip element with multiple radial openings for enhanced guidance.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If the catheter is configured sufficiently rigid to prevent slippage due to blood pressure counter-force, then the balloon position stability is improved, but the catheter flexibility to navigate curved vessel regions deteriorates
Solution Approach 1:
The catheter shaft is divided into multiple segments with different rigidity characteristics. A proximal segment provides rigidity to prevent slippage against blood pressure counter-force, while a distal segment maintains flexibility to navigate curved vessel regions. This segmentation allows the catheter to simultaneously achieve both position stability and navigational adaptability.
Solution Approach 2:
Different portions of the catheter shaft are assigned different mechanical properties. The proximal portion is configured with higher rigidity to resist slippage forces, while the distal portion maintains lower rigidity for flexibility. This local differentiation of material properties enables the catheter to satisfy both contradictory requirements in different spatial locations.
2Adaptability or versatility
If multiple lumens are added for pressure monitoring and pharmacological substance introduction, then the functionality is improved, but the device complexity increases
Solution Approach 1:
The catheter is designed as a multi-lumen structure where each lumen serves a specific function: one lumen for balloon inflation, another for pressure monitoring, and additional lumens for introducing pharmacological substances. This multi-functional design allows a single catheter device to perform multiple therapeutic and diagnostic functions simultaneously, improving versatility while managing complexity through integrated design.
Solution Approach 2:
Multiple functional elements (inflation system, pressure monitoring system, pharmacological delivery system) are merged into a single integrated catheter structure. The various lumens are combined within a unified catheter shaft, allowing all functions to be delivered through one device rather than requiring separate devices for each function.
3Ease of operation
If the catheter is made flexible to navigate curved vessel regions, then the ease of introduction is improved, but the catheter may buckle under blood pressure during occlusion
Solution Approach 1:
The catheter shaft is segmented into proximal and distal portions with different rigidity characteristics. The proximal segment provides buckling resistance to withstand blood pressure during occlusion, while the distal segment maintains flexibility for easy navigation through curved vessel regions. This segmentation resolves the contradiction between introduability and buckling resistance.
Solution Approach 2:
Different mechanical properties are assigned to different locations along the catheter shaft. The proximal portion has higher rigidity to prevent buckling under pressure, while the distal portion has lower rigidity to enable flexible navigation. This local quality differentiation allows the catheter to simultaneously achieve ease of introduction and structural strength.
Data Source
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AI summary
In a balloon catheter for introduction into a body vessel, in particular the coronary sinus, and for intermittently occluding the same, comprising a catheter shaft (155) that carries an inflatable balloon (122) on a distal end portion and a plurality of lumens extending through the catheter shaft (155), a pressure sensor lumen (125) extending centrally through the catheter shaft (155) to at least one distal opening (127,128) is provided, the at least one distal opening (127, 128) being arranged distally of the balloon (122) for communication with the fluid in the body vessel. Furthermore, an inflation lumen (158) to inflate and deflate the balloon (122) is provided, wherein the catheter comprises a stiffening element (123) extending along the catheter shaft (155), the stiffening element (123) having a distal end portion (164) that is positioned adjacent to the proximal end of the balloon (122) and has a flexural strength reduced relative to a remaining portion of the stiffening element (123).