Expandable Braided Introducer Sheath for Minimally Invasive Valve Delivery
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Solution Overview
Problem
Conventional devices for transcatheter delivery of collapsible prosthetic heart valves face challenges such as vascular trauma due to large introducer sizes, limited expansion capabilities, and difficulties in minimizing vessel trauma during insertion.
Innovation Solution
The introduction of an expandable introducer sheath made from a braided material covered with an elastomeric material, which can transition from a collapsed to an expanded condition, allowing for a smaller initial diameter for insertion and larger diameter for device delivery, thereby reducing vascular trauma.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Volume of moving object
If a large diameter introducer sheath is used to deliver collapsible prosthetic heart valves, then the valve can be delivered to the implant site, but vascular trauma increases
Solution Approach 1:
The introducer sheath transitions from a compressed low-profile state during insertion to an expanded high-capacity state at the implant site. The sheath body includes an expandable section with radially spaced apart struts that can be deployed from a compressed configuration to an expanded configuration, allowing the sheath to accommodate larger diameter prosthetic heart valves while maintaining a small insertion profile that minimizes vascular trauma
Solution Approach 2:
The expandable sheath employs a nested structure where the expandable section with struts is contained within the introducer body in a compressed state during insertion. Once positioned at the implant site, the struts are deployed outward to expand the sheath lumen, creating a larger delivery channel for the prosthetic heart valve while the outer sheath structure remains in place to provide support and protection
2Object-affected harmful factors
If the introducer sheath is made expandable to reduce insertion diameter, then vascular trauma is reduced, but the device complexity increases
Solution Approach 1:
The expandable sheath incorporates a flexible structure with radially spaced apart struts that can be collapsed into a low-profile configuration for insertion and then expanded at the implant site. The sheath body includes an expandable section with these struts that can transition between compressed and expanded states, providing the necessary flexibility and shape-changing capability while maintaining structural integrity
Solution Approach 2:
The introducer sheath is divided into distinct functional sections: a proximal section, an expandable section with deployable struts, and a distal section. This segmentation allows the expandable portion to be positioned and deployed independently at the implant site while the rest of the sheath remains in place, simplifying the overall deployment sequence and reducing the complexity of coordinating multiple moving parts
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
This solution enables minimally invasive delivery of prosthetic heart valves with reduced risk of vascular trauma, as the sheath can expand to accommodate larger devices while maintaining a small profile for insertion, thus facilitating safer and more effective procedures.
Implementation Method 1
the body having a braided material and an elastomeric material covering the braided material, the body having a collapsed condition and an expanded condition
Data Source
AI summary
In some examples, an introducer sheath extends from a proximal end to a distal end, and includes a hub disposed at the proximal end, and a body coupled to the hub and extending between the proximal end and the distal end, the body defining a lumen and having a collapsed condition and an expanded condition, the body having a braided material and an elastomeric material covering the braided material, the body having a flared distal end.