Segmented Catheter Hub With Flexible Arm Valve Gap
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Solution Overview
Problem
The process of removing a tubular member from around a medical device after placement can be difficult and time-consuming, potentially disturbing the device's placement, especially when trying to remove a delivery sheath from a cardiac lead without dislodging it.
Innovation Solution
A hub system for sheaths and catheters with a valve mechanism that includes a first and second hub portion aligned with a gap to accommodate a valve, allowing for easy insertion and secure capture of the valve, providing a fluid-tight seal and facilitating the removal of the tubular device without disturbing the medical device placement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a delivery sheath is used to deliver a medical device, then the medical device can be delivered and placed in the body lumen, but the removal of the delivery sheath from around the medical device becomes difficult and time-consuming
Solution Approach 1:
The hub is divided into two separate portions (first hub portion and second hub portion) that are coupled by a flexible hub arm, creating a segmented structure. This segmentation allows the hub to be opened by separating the portions, facilitating easy removal of the delivery sheath from around the medical device without disturbing the device placement.
Solution Approach 2:
The hub arm is designed to be flexible, allowing the hub to transition from a closed configuration during delivery to an open configuration during removal. This dynamic flexibility enables the hub portions to be directed away from each other, creating space for sheath removal while maintaining structural integrity during the procedure.
2Reliability
If a delivery sheath is used to deliver a medical device, then the medical device can be delivered and placed in the body lumen, but the removal process may disturb the placement of the medical device
Solution Approach 1:
The segmented hub structure with two portions coupled by a flexible arm allows the delivery sheath to be removed by opening the hub, rather than pulling the sheath through a confined space. This segmentation enables easy manipulation and removal without applying forces that could disturb the medical device placement.
Solution Approach 2:
The flexible hub arm acts as an intermediary element between the two hub portions, allowing controlled movement and separation. This intermediary structure facilitates the removal process by providing a mechanism to open the hub and release the sheath without direct manipulation that could affect the medical device.
3Reliability
If a valve is added to provide fluid-tight seal, then hemostasis and agent infusion are improved, but the hub structure becomes more complex
Solution Approach 1:
The valve is integrated into the hub structure by securing it within the gap between the two hub portions, merging the sealing function with the existing hub architecture. This integration provides fluid-tight seal for hemostasis and agent infusion without requiring a completely separate valve assembly, thus limiting the increase in structural complexity.
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 hub system enables efficient delivery and secure placement of medical devices while allowing for easy removal of the tubular device without dislodging the medical device, maintaining a fluid-tight seal and reducing procedural time and risk.
Implementation Method 1
The hub arm may be sufficiently flexible such that the first hub portion may be directed away from the second hub portion to increase a size of the gap
Implementation Method 2
the hub arm may be resiliently biased to return towards its original shape to capture a valve within the gap
Data Source
Figure 1A~1B
Figure 2A~3
Figure 4A~4C
AI summary
A hub for a sheath, catheter, or other tubular device includes a first hub portion including a first hub lumen sized for receiving a medical device therethrough, and a second hub portion including a second hub lumen, the second hub portion coupled to the first hub portion such that the first and second hub lumens are aligned with one another and the first and second hub portions are spaced apart from one another to define a gap. A valve is secured within the gap between the first and second hub portions that includes a valve passage therethrough, e.g., for accommodating receiving a medical device through the first and second hub lumens into the tubular device, while providing a substantially fluid tight seal. For example, the valve passage may include a bore extending partially from a first end of the valve towards a second end of the valve, and a slit that extends from the end of the bore to the second end of the valve.