Repositioning Sheath for Mechanical Circulatory Support
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Solution Overview
Problem
Existing mechanical circulatory support systems face challenges with the introduction and removal of sheaths at vascular access sites, leading to issues such as vessel trauma and inadequate blood perfusion due to the large outer diameter of introducer sheaths.
Innovation Solution
The use of a repositioning sheath with a smaller outer diameter than the introducer sheath, which can longitudinally adjust over the elongate shaft and be configured to extend entirely through the introducer sheath, facilitating improved blood perfusion and reducing the need for peel-away sheaths.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If an introducer sheath with large outer diameter is used to deliver the blood pump, then the blood pump can be successfully delivered through the vascular access site, but the large sheath diameter causes vessel trauma and inadequate blood perfusion
Solution Approach 1:
The sheath system is divided into two separate sheaths: an introducer sheath for initial delivery and a repositioning sheath for final positioning. This segmentation allows each sheath to have optimized diameter for its specific function, with the repositioning sheath having a smaller diameter to reduce vessel trauma after the blood pump is delivered.
Solution Approach 2:
The repositioning sheath is nested within the introducer sheath during delivery. The repositioning sheath can slide through the introducer sheath to enable independent positioning. This nested configuration allows the smaller repositioning sheath to be delivered through the larger introducer sheath while maintaining its own optimized diameter for reduced vessel trauma.
2Ease of repair
If a peel-away sheath is used to remove the introducer sheath, then the introducer sheath can be removed from the vascular access site, but the process is complex and time-consuming
Solution Approach 1:
The repositioning sheath is extracted from the introducer sheath and used as a standalone component for final positioning. This extraction eliminates the need for complex peel-away mechanisms, as the repositioning sheath can be independently removed or left in place to maintain vascular access, simplifying the overall removal process.
3Manufacturing precision
If the repositioning sheath is configured to longitudinally adjust over the elongate shaft, then the medical devices can be precisely positioned, but the sheath configuration becomes more complex
Solution Approach 1:
The repositioning sheath is designed with longitudinal adjustability over the elongate shaft, allowing dynamic positioning along the shaft length. This dynamic configuration enables precise positioning of the blood pump at the desired location while maintaining a relatively simple sheath structure through the use of a hub assembly for securing the sheath at the proximal end.
Data Source
AI summary
A mechanical circulatory support system may include a blood pump, a housing, an elongate shaft, a first sheath, and a second sheath. The blood pump may be configured to pump blood from a ventricle of a heart of a patient to vasculature of the patient. The elongate shaft may be coupled with the blood pump and extend proximally from the blood pump to the housing. The first sheath may extend over the elongate shaft distal of the housing and include a lumen with an inner diameter. The second sheath may extend over the elongate shaft distal of the housing and include an outer diameter that is less than the inner diameter of the lumen of the first sheath. The first sheath and the second sheath are configured to longitudinally adjust over the elongate shaft and an entirety of the second sheath is configured to adjust through the first sheath.