Heart Valve Delivery Catheter With Suture Recapture Release
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Solution Overview
Problem
Developing prostheses, particularly replacement heart valves, that can be compacted for delivery and controllably expanded for secure placement within the body while minimizing trauma, and addressing challenges in accessing and deploying them through tortuous vasculature or anatomical locations.
Innovation Solution
A delivery system utilizing a suture-based release mechanism with dual coaxial sliding shafts and a suture-based release mechanism to facilitate controlled deployment and securement of replacement heart valves, including a transseptal approach for mitral valve delivery, and components like a capsule, outer sheath, rail, mid-shaft, and nose cone subassemblies for precise placement and recapture.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If a cutting tool is used to incise the delivery catheter to expand the compressed heart valve, then the heart valve can be deployed from the compressed state to the expanded state, but cutting tools and techniques must be avoided to prevent damage to the heart valve or delivery catheter
Solution Approach 1:
A non-cutting expansion tool is introduced as an intermediary device between the compressed heart valve and the expansion force. This tool applies radial expansion forces through mechanisms such as balloon inflation, polymeric foam expansion, or mechanical expansion elements that push against the valve framework without cutting or damaging the valve or delivery catheter, thereby resolving the contradiction between achieving precise deployment and avoiding damage.
2Ease of operation
If the compressed heart valve is delivered through a delivery catheter to the implantation site, then the valve can be implanted minimally invasively, but the delivery catheter must be navigated through the patient's vasculature which increases procedural complexity
Solution Approach 1:
The delivery catheter is designed with multi-functional capabilities including navigation through vasculature, positioning at the implantation site, controlled expansion of the heart valve, and potential retrieval or adjustment functions. This universal design consolidates multiple procedural steps into a single integrated device, reducing overall procedural complexity while maintaining minimally invasive benefits.
3Volume of moving object
If the heart valve is compressed to a small size for delivery, then it can be delivered through narrow vasculature, but the compressed state requires expansion at the implantation site which introduces additional steps and potential complications
Solution Approach 1:
The heart valve is pre-compressed to a small size within the delivery catheter before delivery, and the expansion mechanism is pre-positioned and prepared within the catheter. The expansion tool and force application mechanism are readied in advance during delivery, so that upon reaching the implantation site, expansion can be initiated immediately with a single action, reducing the number of additional steps and potential complications.
Data Source
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Figure 2A
AI summary
A delivery system includes a suture attachment mechanism for maintaining a connection to a heart valve after initial deployment, thereby allowing recapture of the heart valve if desired. A plurality of suture portions is provided along a distal end portion of the delivery system, each suture portion having a first end fixed to the delivery system and a second end releasably coupled to a retention member on the delivery system. A knob on a handle of the delivery system is actuated for causing the second end of each suture portion to be released from its respective retention member, thereby allowing the suture portions to be decoupled from the heart valve. The suture portions are located only along a distal end portion of the delivery system for improving reliability and consistency.