Valve Delivery Tool With Constrictable Loop For Heart Valve Implantation
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Solution Overview
Problem
Current delivery systems for implantable medical devices with self-expanding frames, such as prosthetic heart valves, lack efficient tools for minimally invasive implantation, particularly in terms of easy use, rapid connection, precise visualization, and control over valve positioning and expansion.
Innovation Solution
The development of minimally invasive sutureless valve delivery tools with a side-mounted holder that allows for easy connection, visualization of valve seating, and controlled expansion, featuring a controllably constrictable and expandable loop system to manage the self-expanding frame's deployment and repositioning.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a traditional delivery system is used for implanting self-expanding prosthetic heart valves, then the implantation process is complex and time-consuming, but the delivery tool lacks ease of operation and rapid connection capability
Solution Approach 1:
The delivery system is divided into separate modular components: a handle assembly, a delivery catheter, and a self-expanding frame with valve. This segmentation allows each component to be optimized independently and facilitates rapid assembly and disassembly during the implantation procedure, directly improving ease of operation while managing overall system complexity.
Solution Approach 2:
The self-expanding frame with valve is nested within the delivery catheter in a compressed state, allowing it to be delivered through a minimally invasive approach. The nested configuration enables compact delivery while maintaining the full functionality of the expanded valve, simplifying the implantation process without requiring complex deployment mechanisms.
2Productivity
If a traditional delivery system is used, then connection between the delivery tool and valve is time-consuming, but the system lacks rapid connection capability
Solution Approach 1:
The self-expanding frame is pre-assembled with the valve and delivery catheter in a factory setting, with all necessary connections and configurations completed beforehand. This preliminary action eliminates the need for complex intra-procedural assembly, enabling rapid deployment during implantation and significantly reducing connection time while improving overall productivity.
3Difficulty of detecting and measuring
If a traditional delivery system is used, then visualization of valve seating is difficult, but the system lacks improved visualization capability
Solution Approach 1:
The delivery system incorporates visual indicators such as color-coded markers or radiopaque elements on the self-expanding frame and delivery catheter. These visual cues change or become visible under fluoroscopic guidance, allowing the surgeon to easily detect valve seating position and orientation without requiring complex imaging systems, thereby improving visualization while minimizing information loss.
4Manufacturing precision
If a traditional delivery system is used, then control over valve positioning and expansion is limited, but the system lacks solid control capability
Solution Approach 1:
The delivery system employs a dynamic control mechanism where the self-expanding frame can be progressively deployed from a compressed to an expanded state through controlled manipulation of the delivery catheter. This dynamic approach allows the surgeon to adjust valve positioning in real-time during deployment, achieving precise placement while maintaining ease of operation through intuitive mechanical control.
Data Source
AI summary
A system includes a medical device for implanting in a valve of a subject, the implantable medical device having a self-expanding frame; and a holder configured to retain the frame of the implantable medical device in a constricted configuration and to control expansion of the frame. The holder has a controllably constrictable and expandable loop, wherein the loop is disposed about at least a portion of the self-expanding frame such that constriction or expansion of the first loop controls constriction or expansion of the frame.