Straight-Loading Introducer Sheath Hub for Sealed Multi-Device Access
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Solution Overview
Problem
Existing introducer sheaths struggle with inserting multiple medical devices simultaneously while maintaining hemostasis and allowing for repositioning, as they often cause blood leakage and alignment issues during device insertion.
Innovation Solution
The introducer sheath assembly features a hub with a longitudinal port introducer that includes multiple access ports, elastomeric seals, and a seal displacement mechanism, allowing for simultaneous insertion and repositioning of medical devices like catheters and blood pumps without blood leakage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a traditional introducer sheath with a single hub port is used, then the structure is simple, but it cannot accommodate simultaneous insertion of multiple medical devices without causing alignment issues and blood leakage
Solution Approach 1:
The hub is segmented into multiple access ports (first access port, second access port, third access port) arranged at different angles, allowing each port to receive and guide a separate medical device independently. This segmentation enables simultaneous insertion of multiple devices while maintaining proper alignment and preventing blood leakage through each dedicated pathway.
Solution Approach 2:
The introducer sheath hub is designed with multi-functionality to serve multiple purposes: it provides simultaneous access for multiple medical devices, maintains hemostasis through integrated seals, allows independent positioning of each device, and prevents blood leakage. The universal design accommodates various device types (catheters, blood pumps, etc.) through its multiple angled access ports.
2Adaptability or versatility
If multiple access ports are added to the hub, then multiple medical devices can be inserted simultaneously, but the alignment of devices with the sheath lumen becomes more difficult
Solution Approach 1:
The access ports are arranged asymmetrically at specific angles relative to the longitudinal axis of the sheath. The first access port extends at a first angle, the second access port at a second angle, and the third access port at a third angle. This asymmetric angular arrangement allows each port to be optimally positioned for receiving its respective medical device while maintaining proper alignment with the central lumen, preventing misalignment issues during simultaneous insertion.
3Ease of operation
If a single access port is used, then the hub structure is simple, but it cannot provide independent positioning and repositioning of multiple medical devices
Solution Approach 1:
The hub incorporates dynamic positioning capabilities through multiple access ports that allow independent movement and repositioning of each medical device. The sealed access ports enable devices to be advanced, retracted, and repositioned independently without compromising the hemostatic seal. This dynamic design provides operational flexibility for adjusting device positions during procedures while maintaining a relatively simple overall hub structure.
4Device complexity
If multiple medical devices are inserted through a single port, then the hub remains simple, but blood leakage occurs past the devices
Solution Approach 1:
The hub is divided into multiple sealed access ports instead of a single port, with each port equipped with its own sealing mechanism. This segmentation ensures that each medical device passes through a dedicated sealed pathway, preventing blood from leaking past devices. The separate sealed ports maintain hemostasis reliability while accommodating multiple devices simultaneously without requiring complex additional components.
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
Facilitates the concurrent insertion and repositioning of multiple medical devices through the sheath while maintaining hemostasis, reducing mechanical stress and alignment issues, and ensuring efficient blood vessel access.
Implementation Method 1
at least one of the access ports in the longitudinal port introducer includes an elastomeric seal
Implementation Method 2
The first access port extends at an oblique angle from the second access port... redirecting the medical device to align with the longitudinal axis of the sheath
Data Source
AI summary
An introducer sheath assembly includes an introducer sheath including a hub at the proximal end region of the introducer sheath and an elongate shaft extending distally from the hub. The hub defines a port in fluid communication with a lumen extending through the elongate shaft. A longitudinal port introducer is coupled to and extends proximally from the port of the hub. The longitudinal port introducer includes a housing defining a passageway extending therethrough and a plurality of access ports in the housing, the plurality of access ports including a first access port and a second access port, wherein one of the first and second access ports is axially aligned with the longitudinal axis of the elongate shaft and hub.