Hemostasis Bypass Valve Actuator Mechanism
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Solution Overview
Problem
Existing medical devices, such as collapsible and expandable occluders, face challenges when passing through hemostasis valves due to low column strength and potential contamination from silicone oil, which can cause damage and contamination during deployment.
Innovation Solution
A delivery device with a hemostasis bypass assembly that includes a bypass tube coupled to an actuator, allowing the bypass tube to transition between positions proximal and distal to the hemostasis valve, reducing resistance and contamination risk by bypassing the valve during device passage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a collapsible and expandable medical device with low column strength is passed through a hemostasis valve, then the device can be delivered to the target location, but the device may buckle or become damaged due to insufficient structural support
Solution Approach 1:
A bypass tube is introduced as an intermediary structural element that provides temporary support to the low column strength medical device during passage through the hemostasis valve. The bypass tube acts as a mediator that prevents buckling of the collapsible device while allowing it to maintain its collapsed, low-profile configuration for delivery.
Solution Approach 2:
The bypass tube is designed to be dynamically deployable and retrievable. It transitions from a compressed state during delivery to an expanded state during valve passage to provide support, then returns to a compressed state after valve passage. This dynamic behavior allows the system to adapt structural support levels to the specific needs of each procedural phase.
2Adaptability or versatility
If a medical device is passed through a hemostasis valve, then the device can be delivered to the target location, but silicone oil from the valve may contaminate the device
Solution Approach 1:
The bypass tube serves as an intermediary passage that allows the medical device to bypass the hemostasis valve entirely. By creating an alternative route through the bypass tube, the device never contacts the silicone oil contained within the valve, thus preventing contamination while still enabling device delivery through the same access point.
3Ease of operation
If a hemostasis bypass assembly with a deployable bypass tube is added to the delivery device, then resistance and contamination risk are reduced during device passage, but the device complexity increases
Solution Approach 1:
The bypass tube is integrated into the existing delivery device architecture rather than being a separate component. The bypass tube is coupled to the delivery device and can be deployed from it, merging the bypass functionality with the delivery system. This integration reduces the number of separate components and simplifies the overall system while still providing the benefits of reduced resistance and contamination risk.
Data Source
AI summary
According to one aspect of the disclosure, a delivery device may include a handle, a catheter sheath extending distally from the handle, and a hemostasis valve positioned within the handle. The hemostasis valve may be located proximal the catheter sheath and distal to a proximal end of the handle. The delivery device may also include a hemostasis bypass assembly coupled to the handle. The hemostasis bypass assembly may include a bypass tube coupled to an actuator. The actuator may be configured to be transitioned between a first condition in which a distal end of the bypass tube is positioned proximal to the hemostasis valve and the hemostasis valve is closed, and a second condition in which the distal end of the bypass tube traverses the hemostasis valve and the hemostasis valve is opened.