Integrated Expandable Sheath Assembly for Low-Bleeding Pump Access
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Solution Overview
Problem
Current peel-away introducer sheaths for medical devices, such as heart pumps, require a larger vessel opening due to their non-expandable nature, leading to complications like bleeding, vascular issues, and increased procedural complexity, while expandable sheaths are limited by short-term use and lack of thrombosis prevention and vessel sealing.
Innovation Solution
An expandable introducer sheath assembly that integrates with a repositioning sheath, allowing for a smaller puncture size and minimizing friction and axial load, while remaining in the insertion path for extended durations, reducing thrombosis risk and simplifying the insertion process by eliminating the need for peel-away steps.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a peel-away introducer sheath is used, then the pump assembly can be inserted through the vascular system, but the sheath creates an opening wider than necessary and requires peeling away which complicates the procedure and risks bleeding or vascular complications
Solution Approach 1:
The introducer sheath transitions from a static non-expandable structure to a dynamic expandable structure that can change its diameter. The sheath expands radially to accommodate the pump assembly during insertion, then maintains a smaller profile afterward, eliminating the need for peeling away and reducing procedural complexity while preventing bleeding and vascular complications.
2Device complexity
If a non-expandable introducer sheath is used, then the structure is simple, but the inner diameter must be large enough for the largest component, creating excessive opening size and friction
Solution Approach 1:
The sheath dynamically adjusts its diameter to match the specific device being inserted, expanding only when needed during the insertion phase. This reduces friction and axial load on the vessel while maintaining structural simplicity, as the expansion capability is integrated into the basic sheath design rather than requiring complex mechanisms.
3Ease of operation
If the introducer sheath is peeled away after insertion, then the pump can be positioned, but this creates bleeding risks and vascular complications
Solution Approach 1:
The sheath expands during insertion to facilitate pump deployment, then contracts to a smaller profile that seals against the vessel wall, preventing bleeding and vascular complications. The dynamic size change allows the sheath to remain in place without peeling, eliminating the harmful effects associated with sheath removal while maintaining ease of pump repositioning.
4Ease of operation
If an expandable sheath is used for short-term use, then the insertion is facilitated, but thrombosis prevention and long-term vessel sealing are not addressed
Solution Approach 1:
The sheath expands during insertion to facilitate device delivery, then contracts to create a seal against the vessel wall that prevents thrombosis and ensures long-term vessel sealing. The dynamic transition from expanded to contracted state addresses both insertion ease and long-term reliability by adapting the sheath profile to different procedural phases.
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
The expandable sheath assembly reduces the risk of bleeding and vascular complications, minimizes thrombosis, and simplifies the insertion procedure by maintaining the introducer in place, thus enhancing procedural safety and efficiency.
Implementation Method 1
the second lumen being expandable to allow the passage of the first sheath containing the portion of the medical device
Implementation Method 2
minimizing friction and axial load
Implementation Method 3
reduces the risk of bleeding and vascular complications
Data Source
AI summary
An integrated sheath assembly for inserting a medical device such as a percutaneous pump into a vessel can include a first sheath having a first lumen defining a first opening between proximal and distal ends of the first sheath for passage of a portion of the pump and a second sheath having a second lumen defining a second opening between proximal and distal ends of the second sheath. The second lumen is expandable to allow passage of the first sheath containing the portion of the pump. The first sheath fills a space between the second sheath and the portion of the percutaneous pump when the first sheath containing the percutaneous pump is inserted into the second lumen. The first sheath has a first hub, and the second sheath has a second hub. In some embodiments, a single sheath and a movable connector can be integrated on the medical device.