Suture Rigging Assembly for Collapsing Prosthetic Heart Valves
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Solution Overview
Problem
Existing minimally invasive cardiac procedures face challenges in collapsing and maintaining prosthetic heart valves in a partially collapsed state for deployment, which is difficult and time-consuming, and there is a need for devices that assist in this process to reduce trauma and procedural complications.
Innovation Solution
A suture rigging assembly with a coupling ring and tethers, featuring apertures and suture threads, is used to attach and maintain prosthetic heart valves in a collapsed state, allowing for secure attachment to a delivery device and balanced tensile load distribution during deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If manual collapsing methods are used for prosthetic heart valves, then the valve can be collapsed into the delivery catheter, but the process is difficult and time-consuming
Solution Approach 1:
The suture rigging assembly is pre-assembled with tethers attached to the coupling ring and pre-positioned around the valve frame. The sutures are threaded through the valve frame structures before the collapsing process begins, allowing the operator to simply pull the tethers to initiate collapsing without complex manual manipulation during the procedure
Solution Approach 2:
The suture rigging assembly acts as an intermediary device between the operator and the valve collapsing process. The tethers and sutures serve as mechanical mediators that translate simple pulling motion into controlled collapsing forces distributed across multiple attachment points on the valve frame
2Ease of operation
If the prosthetic heart valve is collapsed for delivery, then it can be delivered minimally invasively, but it is difficult to maintain the collapsed state until deployment
Solution Approach 1:
The suture rigging assembly provides dynamic control of the valve state. The tethers can be maintained under tension to hold the collapsed state during delivery, and the tension can be released or redistributed to enable deployment. The system transitions smoothly between collapsed and deployed states through controlled manipulation of the suture tensions
Solution Approach 2:
The system controls the valve state by changing the tension parameter in the sutures. When the sutures are taut, the valve remains collapsed; when tension is released or redistributed, the valve expands. This simple parameter change (tension vs. relaxation) provides reliable control over the valve's mechanical state
3Strength
If multiple sutures are used for valve attachment, then the tensile load is distributed evenly, but the risk of entanglement increases
Solution Approach 1:
The suture rigging assembly divides the attachment function into multiple independent tethers, each attached to separate locations on the coupling ring and valve frame. This segmentation allows each suture to carry a portion of the tensile load independently, distributing the stress evenly while keeping individual suture paths separate and manageable to reduce entanglement
Data Source
AI summary
A suture rigging assembly for use with a prosthetic heart valve delivery device includes a coupling ring having a plurality of apertures, and at least one tether coupled to the apertures of the coupling ring and extending distally therefrom. Each tether is formed by two lengths of suture thread, the lengths of suture thread joined together at a position spaced from the coupling ring, and a second joining of the lengths of suture thread forming an attachment loop at the distal end of the tether. The first connection in the tethers collectively define the shortest and longest lengths of each of the tethers, and the attachment loops provide a mechanism to releasably attach the tethers to a prosthetic heart valve. Optionally, knots can be used to join the tethers and one or more tethers may include a radiopaque marker secured thereon between two knots.