Variable Durometer Braided Catheter Shaft for Steerability
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Solution Overview
Problem
Existing ICE catheters face challenges with flexibility, kink resistance, and steerability, which affect their performance and usability in medical procedures.
Innovation Solution
The development of a lined variable braided catheter shaft with a high differential durometer between the distal and proximal segments, combined with an embedded variable braided reinforcement layer, enhances flexibility and kink resistance while facilitating alignment during manufacturing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If a uniform durometer catheter shaft is used, then manufacturing is simpler, but flexibility and steerability are compromised
Solution Approach 1:
The catheter shaft employs different durometer materials in different sections: a softer distal portion (35-55D) for flexibility and steerability, and a harder proximal portion (60-80D) for structural support. This local differentiation allows each section to be optimized for its specific function while maintaining overall manufacturability through co-extrusion or bonding processes.
Solution Approach 2:
The shaft is divided into distinct segments with different mechanical properties - a distal segment with lower durometer and a proximal segment with higher durometer. This segmentation enables independent optimization of flexibility in the distal region and structural integrity in the proximal region, resolving the contradiction between ease of operation and ease of manufacture.
2Ease of operation
If a flexible catheter shaft is used, then steerability improves, but kink resistance deteriorates
Solution Approach 1:
The catheter shaft combines polymeric materials with different durometer values to create a composite structure. The softer distal portion provides flexibility for steering, while the harder proximal portion resists kinking. This composite approach allows both contradictory requirements to be satisfied simultaneously in different sections of the same shaft.
Solution Approach 2:
Different sections of the shaft have different material properties: the distal portion uses softer material (35-55D) for flexibility and steerability, while the proximal portion uses harder material (60-80D) for kink resistance. This local quality differentiation resolves the contradiction between steerability and kink resistance.
3Device complexity
If a single-plane articulation mechanism is used, then device complexity is reduced, but adaptability deteriorates
Solution Approach 1:
The catheter shaft is designed with inherent flexibility and torquability that allows it to dynamically adapt to different steering requirements. The differential durometer construction enables the shaft to be torqued and rotated to facilitate steering in multiple planes without requiring complex mechanical articulation mechanisms, thus maintaining low device complexity while achieving high adaptability.
Data Source
AI summary
An imaging catheter is provided. In one embodiment, the imaging catheter includes a flexible elongate member that includes a proximal portion formed of a first material embedded with a first braid with a first braid pitch; a distal portion formed of a second material embedded with a second braid with a second braid pitch, wherein the second material is a lower durometer than the first material and wherein the second braid pitch is a higher per inch count than the first braid pitch such that the distal portion is more flexible than the proximal portion; a primary lumen extending between the proximal portion and the distal portion; and a plurality of secondary lumens extending between the proximal portion and the distal portion; and an imaging component coupled to the distal portion of the flexible elongate member.