Catheter Stiffening Elements for Buckling Prevention
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Solution Overview
Problem
Existing multi-lumen catheters face difficulties in insertion due to inflexibility, which leads to buckling during placement in blood vessels and challenges in subcutaneous tunneling, requiring cumbersome temporary stiffening methods that are not effective for split-tip catheters.
Innovation Solution
The use of intra-catheter stiffener elements within the catheter lumens to temporarily stiffen and guide the catheter during insertion, allowing for independent stiffening of each lumen and tip, facilitating advancement over guide-wires and proper placement within the vessel without kinking.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the catheter is made flexible to avoid damage to the blood vessel and permit movement in blood flow, then the catheter can be safely placed for extended periods, but the catheter becomes difficult to insert and tends to buckle during placement
Solution Approach 1:
The catheter is divided into multiple segments with different flexibility characteristics. The proximal portion contains stiffening elements for insertion stability, while the distal portion remains flexible for safe vessel placement and movement. This segmentation allows the catheter to exhibit different mechanical properties in different regions during the insertion and placement process.
Solution Approach 2:
The catheter incorporates expandable stiffening elements that can be deployed or collapsed dynamically. During insertion, the stiffening elements are expanded to provide structural support and prevent buckling. Once placed, the stiffening elements are collapsed to allow the catheter to flex and move with blood flow, ensuring safety for extended placement.
2Ease of operation
If a temporary rigid applicator is inserted into one lumen to stiffen the catheter during insertion, then the catheter can be advanced over guide-wire, but the method is cumbersome and presents additional difficulties in maneuvering the instrument
Solution Approach 1:
The stiffening elements are integrated directly into the catheter structure rather than being separate applicators. Multiple stiffening elements are combined within a single catheter body, allowing simultaneous stiffening of multiple lumens without requiring separate applicators for each lumen. This merging reduces procedural complexity and improves maneuverability.
Solution Approach 2:
The catheter contains self-contained stiffening elements that are already positioned within the catheter lumens before insertion. These elements automatically provide the necessary stiffness during advancement over guide-wires without requiring separate applicator insertion or manipulation. The catheter serves its own stiffening needs, eliminating the cumbersome two-step process of applicator insertion followed by catheter advancement.
3Ease of operation
If the catheter is made inflexible to maintain structural integrity during insertion, then the catheter can be easily manipulated during placement, but the catheter tends to buckle and damage the blood vessel
Solution Approach 1:
The catheter exhibits different mechanical qualities at different locations. The proximal portion contains stiffening elements that provide structural integrity and ease of manipulation during insertion and placement. The distal portion remains flexible to conform to vessel geometry and avoid damage. This local differentiation of mechanical properties allows the catheter to be both easy to manipulate and safe for blood vessel placement.
Data Source
AI summary
A catheter assembly including a multi-lumen catheter, a stylet, and a guide-wire. The multi-lumen catheter includes a first lumen in fluid communication with a first distal opening and a second lumen in fluid communication with a second distal opening. The stylet is designed for insertion through the first lumen, having a length greater than a length of the first lumen such that a distal portion of the stylet can extend distal of the first distal opening. The distal portion of the stylet can include a stylet distal opening, a stylet proximal opening in communication with the stylet distal opening, and an expandable portion. The expandable portion can include a first expansion side and a second expansion side at least partially separable from the first expansion side. The stylet proximal opening can be formed through the first expansion side.