Valve Bypass Tool Hinge Design for IMD Delivery
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Solution Overview
Problem
Existing valve bypass tools for implantable medical device delivery systems are bulky and complex, occupying valuable length and causing obtrusiveness during implant and extraction procedures.
Innovation Solution
A compact valve bypass tool with a cylindrical tube and a back panel, featuring a living hinge or mechanical hinge that allows the tool to transition between closed and open states, enabling dilation of the hemostasis seal and allowing for the passage of leadless implantable medical devices without the need for a secondary seal.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a discrete valve bypass tool with elongated housing and integrated seal is used, then the seal can be effectively dilated, but the tool becomes bulky and complex, occupying valuable length of the delivery system
Solution Approach 1:
The valve bypass tool is divided into two separate components: a simple cylindrical dilation element and a back panel with inlet opening. The dilation element can be detached from the back panel, allowing the delivery system to be compact during implantation and only assemble the dilation function when needed at the access introducer site.
Solution Approach 2:
The integrated seal and elongated housing are removed from the valve bypass tool design. Only the essential dilation function remains as a simple cylindrical element, while the back panel serves as a separate interface component. This extraction eliminates unnecessary complexity while preserving the core seal-dilating capability.
2Reliability
If the valve bypass tool remains coupled to the access introducer throughout the procedure, then the seal dilation is maintained, but the bulky tool becomes obtrusive during implant and extraction
Solution Approach 1:
The valve bypass tool transitions from a static, permanently coupled design to a dynamic, selectively deployable design. The cylindrical dilation element can be inserted through the back panel's inlet opening when seal dilation is needed, then removed when no longer required, allowing the system to adapt its configuration based on procedural needs.
Solution Approach 2:
The valve bypass tool is used temporarily during the procedure - inserted when seal dilation is needed for IMD passage, then discarded (removed) when the delivery system is fully positioned or during extraction. This temporary use eliminates obtrusiveness while maintaining functionality when required.
3Reliability
If the guide catheter distal end is forced against the hemostasis seal, then the seal can be dilated, but delicate components such as mechanical fixation elements or protective sleeves may be damaged
Solution Approach 1:
The cylindrical dilation element acts as an intermediary tool between the operator and the hemostasis seal. Instead of forcing the delicate guide catheter distal end against the seal, the dedicated dilation element performs the seal-dilating action, protecting the IMD components from damage while achieving the necessary seal penetration.
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 solution reduces the complexity and length of the delivery system, allowing for easier navigation and reduced risk of damage to delicate components, while providing sufficient structural support to dilate the hemostasis seal effectively.
Implementation Method 1
The tube is cylindrical, and the distal end of the tube is configured to dilate a seal of an access introducer
Data Source
AI summary
A valve bypass tool for an implantable medical device (IMD) delivery system includes a back panel and a tube connected to the back panel and extending from the back panel to a distal end of the tube. The back panel defines an inlet opening. The tube is cylindrical and the distal end of the tube is configured to dilate a seal of an access introducer. The tube defines a channel therethrough that aligns with and is open to the inlet opening in the back panel. The inlet opening and the channel of the tube are sized to receive an IMD therethrough.