Bifurcated Introducer Hub for Single-Site Dual Device Access
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Solution Overview
Problem
The use of multiple medical devices in a patient through multiple access sites poses challenges due to anatomical limitations, increased vascular complications, and procedural complexity, particularly when using devices like the Impella pump and PCI devices, which require separate access points and conventional introducer valves fail to maintain hemostasis and prevent device migration.
Innovation Solution
A dual hub introducer sheath system with a bifurcated hub allowing simultaneous insertion of two medical devices, featuring separate lumens and hemostasis valves, and a locking mechanism to secure devices in place, enabling a single access site for multiple devices.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If multiple medical devices are inserted through multiple access sites, then each device can be delivered independently, but the number of access sites increases and vascular complications increase
Solution Approach 1:
The patent combines multiple access points into a single introducer sheath system. The bifurcated hub provides separate lumens for multiple devices while maintaining a single external access site, thereby reducing the number of puncture sites and associated vascular complications.
Solution Approach 2:
The introducer sheath is segmented into multiple lumens within a single wall structure, allowing independent device passage through each lumen while maintaining a unified access point. This segmentation enables multiple devices to be delivered independently without requiring multiple separate access sites.
2Ease of operation
If conventional introducer valves are used, then device delivery is simple, but hemostasis cannot be maintained and device migration cannot be prevented
Solution Approach 1:
The introducer sheath system provides multiple functions: it serves as both a delivery mechanism for multiple devices and a hemostatic barrier. The balloon occlusion mechanism enables both device delivery and reliable hemostasis maintenance, replacing the single-function conventional introducer valve.
Solution Approach 2:
The system transitions from a static introducer valve to a dynamic balloon occlusion mechanism that can be inflated and deflated as needed. This dynamic capability allows the operator to maintain hemostasis while enabling device delivery and prevention of device migration.
3Object-affected harmful factors
If a single access site is used for multiple devices, then the number of access sites is reduced, but device insertion becomes more complex
Solution Approach 1:
Multiple devices are nested within separate lumens of a single introducer sheath. The bifurcated hub contains multiple lumens that can each accommodate a different device, creating a nested configuration that reduces access sites while managing device complexity through organized spatial arrangement.
4Device complexity
If multiple access sites are used, then procedural complexity is reduced, but hospital costs increase
Solution Approach 1:
The patent merges multiple access site procedures into a single access site procedure. By delivering multiple devices through one introducer sheath, the system reduces the number of puncture sites, closure devices, and associated materials needed, thereby reducing overall procedural costs despite increased device complexity.
Data Source
AI summary
There is provided an introducer system for percutaneously delivering a first and a second medical device to a patient. The system may comprise an introducer sheath having a longitudinal axis and a lumen formed therein. The system may also comprise a bifurcated hub coupled to a proximal end of the sheath. The hub may comprise a first arm having a first lumen and a first hemostasis valve for the passage of the first medical device. The hub may also comprise a second arm coupled to the first arm and having a second lumen and a second hemostasis valve for the passage of the second medical device. Further, the hub may comprise a connection port such that the first lumen and the second lumen are in communication with the lumen of the introducer sheath for the passage of at least one of the first and second medical devices through the introducer sheath for delivery to the patient.