Expandable Iliac Sheath for Minimally Invasive Vascular Access
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current medical devices face challenges in accessing the cardiovascular system, particularly in patients with significant vascular disease, as the removal of large catheters and sheaths can disrupt vessel plaque, leading to emboli and complications, and insertion is difficult due to stenosis and tortuous vessels.
Innovation Solution
An expandable introducer sheath with varying cross-sectional areas, featuring a proximal, central, and distal expandable regions, made from polymeric materials with reinforcing elements, allowing for minimally invasive percutaneous access and expansion to accommodate large interventional devices, reducing tissue trauma and the need for surgical cutdowns.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Area of moving object
If a large diameter catheter or sheath is inserted into the patient, then large devices can be introduced for therapeutic procedures, but insertion becomes difficult or impossible due to vessel stenosis or wall interference
Solution Approach 1:
The sheath is divided into multiple sections with different cross-sectional areas: a first section with a first cross-sectional area for insertion, and a second section with a second cross-sectional area for device introduction. This segmentation allows the sheath to be inserted through stenotic vessels while maintaining the capability to accommodate large interventional devices.
Solution Approach 2:
The sheath transitions from a collapsed, low-profile configuration during insertion to an expanded, high-capacity configuration during device introduction. This dynamic transformation allows the sheath to adapt its cross-sectional area based on the procedural phase, enabling easy insertion through narrow vessels while providing sufficient lumen for large devices.
2Ease of operation
If a large diameter catheter or sheath is removed from the patient, then devices can be withdrawn after procedures, but vessel plaque disruption occurs leading to emboli and complications
Solution Approach 1:
The sheath is divided into a first section and a second section, where the first section can be selectively collapsed to a smaller cross-sectional area. This allows the distal portion to be withdrawn first, minimizing plaque disruption, while the proximal portion remains in place to provide support and control during the withdrawal process.
Solution Approach 2:
The sheath is pre-configured with a collapsible first section that can be reduced in size before withdrawal. This preliminary collapsing action prepares the sheath for safe removal by minimizing its profile and reducing the risk of plaque disruption before the actual withdrawal begins.
3Object-affected harmful factors
If a percutaneous puncture is made to access the artery, then minimally invasive access is achieved, but the access lumen must be minimized while maximizing space for catheter placement
Solution Approach 1:
The sheath dynamically changes its cross-sectional area from a small collapsed profile during insertion through the percutaneous puncture to a large expanded profile for catheter placement. This dynamic adaptation minimizes tissue trauma during puncture while maximizing the access lumen area for device introduction.
Solution Approach 2:
The sheath can be collapsed into a compact configuration that nests within a smaller profile, allowing it to pass through a small percutaneous puncture. Once in position, it expands to provide a large access lumen, effectively nesting the large functional structure within a small insertion profile.
Data Source
Figure 1
Figure 2
Figure 3A~3B
AI summary
Disclosed is ah expandable transluminal sheath, for introduction into the body while in a first, collapsed cross-sectional configuration, subsequent expansion of at least a part of the distal end of the sheath to a second, enlarged cross-sectional configuration, and subsequent removal in a third, collapsed cross- sectional configuration. The sheath is configured for use in the vascular system and has utility in the introduction and removal of implant delivery catheters. The access route is through the femoral arteries and the iliac arteries into the aorta. The distal end of the sheath is maintained in the first, collapsed cross-sectional configuration during advancement to the arteries into the aorta. The distal end of the sheath is then expanded using a radial dilatation device, which is removed prior to the introduction of implant delivery catheters. The distal end of the sheath is subsequently reduced to a diametrically small size for removal.