Expandable Sheath for IABP Removal Vessel Protection
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Solution Overview
Problem
The removal of intra-aortic balloon pumps (IABPs) from patients can cause disruption of vessel plaque, leading to emboli and potential tissue necrosis due to the deflated balloon's sharp edges, especially in patients with significant vascular disease.
Innovation Solution
A transluminal, radially expanding access sheath is used to minimize vessel disruption during IABP removal, allowing the sheath to dilate radially and shield the deflated balloon, preventing contact with vessel walls.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the IABP is removed from the patient, then the cardiac support function is discontinued, but the deflated balloon's sharp edges disrupt vessel plaque and cause emboli
Solution Approach 1:
A protective sheath is introduced as an intermediary device between the deflated IABP balloon and the vessel wall. The sheath envelops the balloon during withdrawal, preventing direct contact between the balloon's sharp edges and the vessel plaque, thereby eliminating the harmful effect while maintaining the removal function
Solution Approach 2:
The protective sheath is positioned around the IABP balloon before withdrawal begins. This pre-positioning creates a protective barrier in advance, cushioning the vessel wall from potential damage by the deflated balloon's sharp edges during the entire removal process
2Object-affected harmful factors
If a protective sheath is used during IABP removal, then vessel wall protection is improved, but the device complexity increases
Solution Approach 1:
The protective sheath is designed to nest over the existing IABP balloon catheter. This nesting configuration allows the protective function to be added without requiring a completely separate system, as the sheath simply envelops the existing device during the withdrawal phase
Solution Approach 2:
The protective sheath serves multiple functions: it protects the vessel wall from balloon edges, maintains a sealed access site during removal, and can be used for other vascular procedures. This multi-functionality justifies the additional component by providing value beyond single-purpose protection
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 effectively protects the vessel walls from the deflated balloon, reducing the risk of emboli and tissue damage during IABP removal, even in patients with severe vascular disease.
Implementation Method 1
A portion of the introducer or sheath, therefore, has a first, smaller cross-sectional profile that can be dilated to a second, larger cross-sectional profile
Data Source
AI summary
Disclosed is an expandable transluminal sheath, for introduction into the body while in a first, low cross-sectional area configuration, and subsequent expansion of at least a part of the distal end of the sheath to a second, enlarged cross-sectional configuration. The sheath is configured for use in the vascular system and has utility in the introduction and removal of balloon counterpulsation catheters. The access route is through the femoral arteries and the iliac arteries into the aorta, where an intra-aortic balloon pump catheter is positioned to provide cardiac support. The distal end of the sheath is maintained in the first, low cross-sectional configuration during advancement to the arteries into the aorta. The distal end of the sheath is subsequently expanded using a radial dilatation device.