Bifurcated Hub for Single-Access Dual-Device Delivery
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Solution Overview
Problem
Current percutaneous mechanical support devices require multiple access sites for simultaneous use, leading to challenges such as limited anatomical access, increased vascular complications, and procedural complexity due to the inability of conventional introducer valves to accommodate dual devices without hemostasis issues and pump migration.
Innovation Solution
A dual hub introducer sheath system with a bifurcated hub design that allows for the simultaneous insertion of two medical devices through separate lumens, featuring dedicated hemostasis valves and a locking mechanism to maintain proper hemostasis and prevent axial movement of devices.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If multiple access sites are used for simultaneous mechanical support devices, then device delivery capability is improved, but vascular complications and procedural complexity increase
Solution Approach 1:
The patent combines multiple access points into a single hub structure that is inserted through one femoral artery access site. The hub contains multiple lumens (first lumen for Impella device, second lumen for PCI catheter) that converge at a single connection port to the introducer sheath, allowing simultaneous delivery of multiple devices through one access point rather than requiring separate arterial punctures.
Solution Approach 2:
The hub structure serves multiple functions: it acts as a common insertion conduit, provides separate hemostatic seals for each device, maintains individual lumens for each device path, and offers a single connection interface to the introducer sheath. This multi-functional design eliminates the need for multiple separate access sites while maintaining device-specific control.
2Adaptability or versatility
If conventional introducer valves are used for multiple devices, then device passage is enabled, but hemostasis control and device stability deteriorate
Solution Approach 1:
The hub is segmented into separate lumens (first lumen and second lumen) that remain distinct throughout the hub structure. Each lumen has its own hemostasis valve (first hemostasis valve and second hemostasis valve) positioned at different locations. This segmentation allows independent hemostatic control for each device pathway, preventing blood leakage issues that would occur with a shared valve.
Solution Approach 2:
The hub acts as an intermediary structure between the introducer sheath and the individual devices. It provides separate hemostasis valves that seal around each device independently while allowing the devices to pass through. The hub's multiple lumens serve as intermediate conduits that maintain device separation and enable individual hemostatic management.
3Ease of operation
If devices are delivered through separate access points, then device insertion is simplified, but anatomical access limitations increase
Solution Approach 1:
The hub structure is nested within the introducer sheath, with multiple lumens contained within the single sheath lumen. The first and second lumens of the hub are each capable of accommodating separate devices (Impella and PCI catheter) while both pass through the same introducer sheath. This nesting approach allows complex multi-device delivery through a single access point.
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.