Slittable Cardiac Delivery Hub With Integrated Bypass
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Solution Overview
Problem
Current delivery devices for cardiac surgical devices face challenges in non-disruptive removal, leading to potential tissue damage and procedural delays due to hub-to-shaft transitional jerk, and require additional tools for navigating hemostasis valves, increasing procedure time and complexity.
Innovation Solution
A slittable delivery device with a shaft integrated into the hub, featuring a consistent slitting medium along its length, and a hemostasis valve bypass tool with a longitudinally extending channel to facilitate smooth removal and reduce the need for secondary tools.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If the hub is made of harder and more rigid material to provide structural support, then the strength and stability of the delivery device is improved, but the force required to slit the hub increases causing transitional jerk
Solution Approach 1:
The hub is segmented into two distinct wall portions: a first wall portion made of harder, more rigid material for structural support, and a second wall portion made of softer, more compliant material that requires less force to slit. This segmentation allows each portion to fulfill its specific functional requirement independently.
Solution Approach 2:
Different regions of the hub wall are assigned different material properties: the first wall portion (e.g., proximal region) uses harder material for strength, while the second wall portion (e.g., distal region) uses softer material for easier slitting. This local differentiation of material quality resolves the contradiction between overall structural strength and localized slitting ease.
2Ease of operation
If a separate valve bypass tool is used to navigate the hemostasis valve, then the passage of soft leads through the valve is facilitated, but the device complexity and procedure time increase
Solution Approach 1:
The valve bypass functionality is merged directly into the delivery device by incorporating a bypass channel through the hemostasis valve. This integration eliminates the need for a separate valve bypass tool, reducing device complexity while maintaining ease of operation for navigating the valve during lead implantation.
Solution Approach 2:
The delivery device is designed with multi-functionality by including an integrated bypass channel that serves both as part of the delivery pathway and as a valve bypass mechanism. This universal design allows the same device to handle both lead delivery and valve navigation functions without requiring additional specialized tools.
3Ease of manufacture
If the shaft and hub are made as separate components, then the manufacturing and assembly are simplified, but the slitting process experiences transitional jerk when moving from hub to shaft
Solution Approach 1:
The hub wall is segmented into two material portions with different properties, creating a gradual transition in material characteristics from the harder first wall portion to the softer second wall portion. This segmentation approach maintains the separate component structure for manufacturing ease while eliminating the abrupt force transition during slitting.
Solution Approach 2:
The material parameters (hardness, compliance) are changed progressively from the first wall portion to the second wall portion of the hub. This parameter transition creates a smooth force profile during slitting, eliminating the abrupt jerk that would occur with a sudden material property change at the hub-shaft interface.
Data Source
AI summary
An assembly for the delivery of a cardiac surgical device is disclosed herein. In one embodiment, the assembly includes a slittable delivery device and a bypass assembly. The slittable delivery device may include a hub, a shaft integrated into the hub and forming at least a segment of the circumferential surface of the hub, and a hemostasis valve contained substantially within the hub. The bypass assembly may include a cap and a valve bypass tool. The cap may be on a proximal end of the hub and may include an opening in the cap extending radially outward from a point near a radial center of the cap through a circumferential edge of the cap. The valve bypass tool may be operably coupled to the cap and may include a longitudinally extending open channel.