Catheter Shaft Helical Wire Reinforcement for Kinking Resistance
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Solution Overview
Problem
Current catheters lack the necessary strength, torqueability, and flexibility to effectively navigate and treat highly occluded blood vessels, often kinking, buckling, or twisting during procedures, and have limited success rates for subintimal insertion and re-entry into true lumens.
Innovation Solution
A catheter shaft body constructed with multiple metal wires of varying sizes and shapes arranged in a spiral configuration and welded at the ends, providing enhanced flexibility, torqueability, and pushability, while maintaining 1:1 torque and translation correspondence between the proximal and distal ends, to prevent kinking and facilitate navigation through occlusions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If polymer-based materials are used for catheter construction, then manufacturing cost is reduced and ease of manufacture is improved, but strength and torqueability are insufficient causing kinking and buckling
Solution Approach 1:
The catheter shaft combines polymer material with a metal wire reinforcement structure to create a composite construction. The polymer provides flexibility and ease of manufacture while the metal wire provides strength and torqueability, resolving the contradiction between ease of manufacture and strength.
Solution Approach 2:
The metal wire reinforcement is strategically positioned within the catheter shaft structure to provide localized strength enhancement where needed, while maintaining the overall flexibility and manufacturability of the polymer-based catheter design.
2Strength
If metal mesh is added to catheter wall, then strength is improved, but flexibility and torqueability remain insufficient for navigating highly occluded vessels
Solution Approach 1:
The metal wire reinforcement is designed with specific local characteristics including wire diameter variations and spatial distribution patterns that provide strength where needed while preserving flexibility in other regions, enabling the catheter to navigate highly occluded vessels.
Solution Approach 2:
The patent employs metal wires with varying diameters and configurations to optimize the balance between strength and flexibility. By changing the parameters of the reinforcement structure, the catheter achieves both the strength required for vessel navigation and the flexibility needed for maneuverability.
3Strength
If catheter is designed with higher strength materials, then pushability and torqueability are improved, but flexibility decreases making it difficult to navigate highly occluded vessels
Solution Approach 1:
The composite structure combines the high strength characteristics of metal wire reinforcement with the flexibility of polymer material, allowing the catheter to achieve both pushability for crossing occlusions and flexibility for navigation through highly occluded vessels.
Solution Approach 2:
The catheter shaft is segmented into distinct functional components: the polymer outer layer providing flexibility and the embedded metal wire providing strength. This segmentation allows each component to optimize its specific function without compromising the other.
4Stability of the object's composition
If catheter shaft is made more rigid to prevent kinking, then torqueability is improved, but ability to navigate tortuous vessel paths is reduced
Solution Approach 1:
The metal wire reinforcement is strategically positioned to provide torqueability in specific regions while maintaining overall flexibility. The local quality of the reinforcement distribution allows the catheter to resist kinking during manipulation while still navigating tortuous vessel paths.
Solution Approach 2:
By varying the parameters of the metal wire reinforcement such as wire diameter, spacing, and configuration, the catheter achieves optimal torqueability while preserving the flexibility needed to navigate complex vessel anatomy.
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
The design significantly improves the catheter's ability to cross chronic total occlusions and sub-intimal entry/exit, increasing success rates for intravascular diagnostic and treatment procedures, ensuring reliable maneuverability and reduced risk of kinking or buckling, thereby transforming difficult procedures into routine ones.
Implementation Method 1
the plurality of wires is helically twisted
Implementation Method 2
wired or otherwise joined or coupled at the ends
Data Source
AI summary
Disclosed is an intraluminal catheter that includes a flexible elongate shaft configured to be positioned within a body lumen of a patient, and an intraluminal sensor disposed at the distal portion of the shaft that is configured to sense a characteristic within the body lumen. The shaft further comprises a plurality of wires disposed around a lumen, wherein the wires are helically twisted. The wires can be helically twisted in a single direction to form a cylindrical shape. This helical structure is configured to stiffen the flexible elongate shaft for movement into an obstruction within the body lumen without kinking.