Splittable Catheter Tube for Wire Guide Control
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Solution Overview
Problem
Current medical devices for biliary procedures face challenges such as loss of wire guide access, incompatibility between long and short wire systems, and leakage issues due to non-patent fluid communication passages, which complicate procedures and reduce efficiency.
Innovation Solution
A medical device system with a splittable catheter shaft that allows for remote uncoupling of the wire guide within the patient, using a flexible tube and a coupling region with a side access port to maintain wire guide control and prevent fluid leakage, enabling efficient exchange of devices over a wire guide without requiring a second lumen.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a long wire guide is used for over-the-wire exchange technique, then wire guide control is maintained at all times, but the procedure requires an assistant and reduces physician control
Solution Approach 1:
The catheter is divided into two functional segments: a coupled portion that remains attached to the wire guide and a uncoupled portion that can be removed independently. This segmentation allows the physician to control the wire guide through the coupled portion while removing the uncoupled portion, eliminating the need for an assistant to manage the entire wire guide length.
Solution Approach 2:
The uncoupled portion of the catheter is extracted or removed from the wire guide after the coupled portion establishes stable access. This extraction allows the physician to maintain control of the wire guide through the coupled portion while eliminating the need to manage the full length of the wire guide, thereby improving ease of operation without sacrificing reliability.
2Ease of operation
If a short wire guide is used for rapid exchange technique, then physician control over the wire is improved, but the catheter must be split or torn away to uncouple from the wire
Solution Approach 1:
The catheter is pre-divided into coupled and uncoupled portions with a defined separation point. This pre-segmentation eliminates the need to split or tear the catheter during the procedure, as the uncoupled portion is already designed to be separable. The coupled portion maintains attachment to the wire guide while the uncoupled portion can be cleanly removed, reducing device complexity compared to requiring mid-procedure catheter splitting.
Solution Approach 2:
The catheter is prepared in advance with a coupled portion and uncoupled portion, where the uncoupled portion is designed to be removable. This preliminary configuration allows for clean separation without requiring forceful splitting or tearing during the procedure, thereby reducing device complexity and improving ease of operation.
3Productivity
If the wire guide exits through a side port in the catheter, then exchange procedure is simplified, but fluid communication passage becomes non-patent causing leakage
Solution Approach 1:
A fluid communication tube acts as an intermediary element, providing a dedicated patent passage for fluid flow from the proximal to distal end of the catheter. This tube runs independently within the catheter structure, ensuring that fluid integrity is maintained even when the wire guide exits through a side port in the coupled portion, thereby resolving the leakage issue without compromising exchange efficiency.
Solution Approach 2:
The catheter's fluid communication function is segmented from its structural function. The fluid communication tube provides a dedicated patent pathway for fluid flow, while the coupled and uncoupled portions handle wire guide attachment and removal. This segmentation allows the wire guide to exit through a side port for efficient exchange while the separate fluid tube maintains patent fluid communication, preventing leakage.
4Reliability
If a second lumen is added to maintain fluid communication, then fluid integrity is preserved, but the device complexity increases
Solution Approach 1:
The fluid communication tube is integrated within the existing catheter structure, merging the fluid communication function with the overall catheter design. Rather than adding a completely separate second lumen, the tube is incorporated into the catheter's construction, thereby preserving fluid integrity while minimizing the increase in device complexity through efficient spatial integration.
Data Source
AI summary
A medical device is provided including a catheter shaft having a lumen extending therethrough with a splittable wall portion along a side of the lumen, and a tube that extends through at least a portion of the lumen and is configured to provide a patent path of fluid communication.


