Split-Frame Cardiac Valve Segmented Delivery
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current transcatheter mitral valve replacement devices face limitations due to their design, requiring large delivery systems that lead to higher complication rates and iatrogenic damage during cardiac procedures, particularly due to radial compression and crimping of prosthetic frames.
Innovation Solution
The development of split-frame cardiac valves configured for non-tubular radially compressed delivery, allowing for lower-diameter catheters and reduced stress on prosthetic leaflets, enabling more controlled deployment and adjustment to match native anatomy, and simplifying manufacturing processes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional radial compression and crimping of prosthetic frames is used, then the valve can be delivered through a catheter, but the delivery system requires large diameter which leads to higher complication rates and bleeding at the access site
Solution Approach 1:
The prosthetic frame is divided into multiple axially-spaced segments that can be independently compressed and expanded. This segmentation allows the frame to be crimped to a smaller profile for delivery while maintaining structural integrity, reducing the required catheter diameter and associated complications
Solution Approach 2:
The frame transitions from a static compressed state during delivery to a dynamic expanded state at the implantation site. The segments are designed to expand radially outward from the compressed configuration, enabling small catheter delivery followed by full-frame deployment at the target location
2Reliability
If conventional radial compression of prosthetic frames is applied, then the valve can be delivered, but the compression stress damages the prosthetic leaflets
Solution Approach 1:
By dividing the frame into segments, the compression force is distributed across multiple independent units rather than concentrating stress on the leaflets. Each segment can be compressed independently, reducing the peak stress any single leaflet experiences during delivery
Solution Approach 2:
The frame segments are pre-configured with compression-resistant structures that protect the leaflets during delivery. The segmented design allows the frame to absorb compression forces without transmitting excessive stress to the delicate prosthetic leaflets
3Ease of manufacture
If conventional closed stent frame design is used, then the valve provides complete coverage, but the manufacturing process is complex and expensive
Solution Approach 1:
The frame is manufactured as separate axial segments that can be produced using simpler processes such as sheet material forming rather than complex laser cutting of continuous tubes. These segments are then assembled to form the complete frame structure, reducing manufacturing complexity and cost
Solution Approach 2:
Multiple separately manufactured frame segments are combined and joined to form the complete prosthetic frame. This assembly approach allows each segment to be optimized for manufacturing efficiency while the final assembled structure provides the required functional coverage
4Ease of operation
If conventional closed stent frame is used, then complete valve coverage is achieved, but the deployment controllability with beating heart is reduced
Solution Approach 1:
The segmented frame design enables dynamic, staged deployment where individual segments can be expanded sequentially or independently. This provides greater operator control during deployment, allowing adjustment to accommodate the beating heart and optimize positioning
Solution Approach 2:
The frame segments are pre-positioned in a compressed state within the delivery catheter, allowing precise navigation to the target site. Upon deployment, the segments expand in a controlled sequence, enabling the operator to pause and adjust positioning during the expansion process to account for cardiac motion
Data Source
AI summary
A split-frame cardiac valve (20) is configured to assume a radially compressed configuration for transcatheter delivery and a radially expanded configuration for anchoring to a native cardiac valve annulus. The split-frame cardiac valve (20) includes circumferential frame segments (22) including respective stents (24) and prosthetic leaflets (30). When the split-frame cardiac valve (20) is in the radially expanded configuration: (a) each of the stents (24) surrounds less than 360 degrees of a central longitudinal axis (26) of the split-frame cardiac valve (20), (b) the circumferential frame segments (22) are slidingly coupled to one another so as to be axially slidable with respect to one another in and out of axial alignment with one another, and (c) when the circumferential frame segments (22) are axially aligned with one another, the stents (24) collectively define a tubular stent (32) that entirely surrounds the central longitudinal axis (26).