Valve Bypass Tool Locking Mechanism for Pacemaker Delivery
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Solution Overview
Problem
Existing bypass tubes used for introducing leadless cardiac pacemakers into access introducers can back out due to proximal force from the hemostasis valve, causing the valve to collapse and potentially damage the pacemaker.
Innovation Solution
A biostimulator transport system equipped with a valve bypass tool that includes a metallic bypass sheath and a polymeric tool body, featuring a locking mechanism to secure the tool to the access introducer, preventing backout and ensuring safe passage of the pacemaker.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a bypass tube is used to open the hemostasis valve for device passage, then the interventional device can be passed through the access introducer, but the bypass tube can back out due to proximal force from the hemostasis valve, causing the valve to collapse and potentially damage the device
Solution Approach 1:
A locking mechanism is introduced as an intermediary component between the bypass tube and the access introducer. This locking mechanism engages with features on both the bypass tube and the access introducer to prevent the bypass tube from backing out while maintaining the hemostasis valve open for device passage.
Solution Approach 2:
The locking mechanism is engaged before device passage to pre-prevent the bypass tube from moving. By securing the bypass tube in the correct position beforehand, the system eliminates the risk of valve collapse during the subsequent device insertion process.
2Object-generated harmful factors
If the hemostasis valve is kept closed to maintain hemostasis, then blood leakage is prevented, but the interventional device cannot be passed through the access introducer
Solution Approach 1:
The bypass tube serves as an intermediary tool that temporarily opens the hemostasis valve to allow device passage. After the device is successfully passed, the bypass tube is removed and the hemostasis valve closes to restore blood leakage prevention.
Solution Approach 2:
The hemostasis valve transitions between closed and open states dynamically. It remains closed to maintain hemostasis, but can be opened by the bypass tube when device passage is required, and then closed again after device insertion is complete.
3Ease of operation
If the bypass tube is made thinner to allow easier device passage, then the device can pass through more easily, but the bypass tube may buckle under insertion forces
Solution Approach 1:
The bypass tube is constructed using composite materials or a composite structure that combines the flexibility needed for device passage with the structural strength to resist buckling. This may involve using materials with specific mechanical properties or a multi-layer construction.
Solution Approach 2:
The bypass tube has varying wall thickness or structural properties at different locations. The section that needs to be thin for device passage has reduced thickness, while sections that need to resist buckling during insertion have increased thickness or reinforcement.
Data Source
AI summary
A valve bypass tool, and a biostimulator transport system having such a valve bypass tool, is described. The valve bypass tool includes an annular seal to seal against a protective sheath of the biostimulator transport system. The valve bypass tool is slidably mounted on the protective sheath and includes a bypass sheath to insert into an access introducer. The valve bypass tool can lock onto the access introducer by mating a locking tab of the valve bypass tool with a locking groove of the access introducer. The locking tab can have a detent that securely fastens the components to resist decoupling when the biostimulator transport system is advanced through the access introducer into a patient anatomy. Other embodiments are also described and claimed.