Flower-Shaped Introducer Sheath for Minimizing Artery Trauma
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Solution Overview
Problem
Conventional delivery devices for self-expanding prosthetic heart valves risk traumatizing iliac or femoral arteries due to large introducer sizes, increasing the risk of trauma with larger diameters.
Innovation Solution
An introducer sheath with a flower-shaped lateral cross-section in its collapsed condition, capable of transitioning to a larger expanded condition when a medical apparatus is passed through, allowing for local expansion only where necessary to accommodate the device and then returning to the collapsed state when the apparatus is removed, minimizing tissue trauma.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a large diameter introducer sheath is used to deliver self-expanding prosthetic heart valves, then the valve can be delivered to the implant site, but the risk of traumatizing iliac or femoral arteries increases
Solution Approach 1:
The introducer sheath transitions from a collapsed low-profile configuration during insertion to an expanded configuration during valve deployment, and back to collapsed during removal. This dynamic shape change allows the sheath to accommodate large-diameter valves during delivery while maintaining a small profile during artery traversal, thereby resolving the contradiction between successful valve delivery and minimization of tissue trauma.
Solution Approach 2:
The prosthetic heart valve is nested within the introducer sheath in a collapsed state, allowing the valve to be delivered through a small-profile sheath. The valve expands to its full diameter only after the sheath has been positioned at the implant site, eliminating the need for a permanently large-diameter sheath and thus preventing artery trauma while ensuring successful valve delivery.
2Object-affected harmful factors
If a collapsible prosthetic valve is delivered through a catheter to avoid open-chest surgery, then the invasiveness of the procedure is reduced, but the valve must be collapsed to a small circumferential size which complicates the delivery device design
Solution Approach 1:
The introducer sheath dynamically changes its cross-sectional shape from collapsed to expanded and back to collapsed, allowing it to accommodate the valve in different states without requiring complex mechanical expansion mechanisms. This dynamic behavior simplifies the overall delivery system while maintaining minimal invasiveness throughout the procedure.
Solution Approach 2:
The introducer sheath changes its physical parameters (cross-sectional shape, diameter) in response to the valve's state and procedural requirements. The sheath transitions between collapsed and expanded configurations based on whether the valve needs to be inserted, deployed, or removed, thereby simplifying the delivery device design while achieving the goal of reduced invasiveness.
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 introducer sheath reduces the risk of tissue trauma by allowing for the passage of larger medical devices while maintaining a smaller profile when not in use, providing a secure and minimally invasive delivery method for prosthetic heart valves.
Implementation Method 1
an introducer sheath includes a body having a lumen extending between a leading end and a trailing end and having a collapsed condition, the body being configured to transition from the collapsed condition to an expanded condition when an apparatus is passed through the lumen
Implementation Method 2
The first lateral cross-section is flower-shaped in the absence of external forces to the body and includes a plurality of petals each including an enlarged head and a tailored neck region
Implementation Method 3
removing the medical apparatus from the lumen of the body, whereby the body returns from the expanded condition to the collapsed condition
Data Source
Figure 1A~1B
Figure 2
Figure 3A~3B
AI summary
An introducer sheath (600) includes a body (605) having a lumen (608) extending between a leading end (604) and a trailing end (602) and having a collapsed condition with a first lateral cross-section (6C1), the first lateral cross-section being flower-shaped, the body being configured to transition from the collapsed condition to an expanded condition with a second lateral cross-section (6C2) when an apparatus is passed through the lumen, the second lateral cross-section having a maximum dimension larger than a maximum dimension of the first lateral cross-section.