Heart Valve Leaflet Stitching for Reduced Profile
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Solution Overview
Problem
Existing replacement heart valves have a large profile in their unexpanded configuration, which requires a larger catheter for insertion, increasing the risk of damage to the body lumen during percutaneous implantation, and they lack sufficient strength for reliable function.
Innovation Solution
A method of forming a replacement heart valve by attaching valve leaflets via sutures in specific patterns, such as whip stitches and running stitches, to minimize the profile while maintaining structural integrity and strength for expansion and function.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the replacement heart valve is designed with a larger profile to ensure structural strength and reliability, then the valve can expand and function reliably, but a larger catheter is required which increases the risk of damage to the body lumen
Solution Approach 1:
The replacement heart valve is designed with a nested structure where the leaflets are positioned within a delivery catheter in a compressed, low-profile configuration. Upon deployment, the leaflets expand outward to their full functional size. This nesting approach allows the valve to pass through a smaller catheter while maintaining its required structural strength and functional dimensions when deployed.
Solution Approach 2:
The replacement heart valve transitions from a static, small-profile configuration during delivery to a dynamic, expanded configuration during deployment. The leaflets are designed to be flexible and adaptable, allowing them to compress for delivery and then expand to their full functional size, changing their physical state to resolve the contradiction between profile size and structural strength.
2Object-affected harmful factors
If the replacement heart valve is designed with a smaller profile to minimize catheter size and reduce risk of body lumen damage, then catheter size is reduced, but the valve may lack sufficient strength for reliable expansion and function
Solution Approach 1:
The valve components are nested within the delivery catheter in a compact arrangement that minimizes the profile during delivery. The leaflets are positioned in a folded or compressed state, allowing them to pass through the catheter with minimal cross-sectional area while maintaining their full structural integrity for when they are deployed.
Solution Approach 2:
The replacement heart valve utilizes dimensional transformation by compressing the leaflets in the radial dimension during delivery, then expanding them in the radial dimension during deployment. This dimensional change allows the valve to have a small profile during catheter passage while achieving full functional dimensions for reliable operation.
3Reliability
If the valve leaflets are attached with extensive stitching to ensure structural integrity and strength, then the valve maintains reliability, but the manufacturing process becomes more complex and time-consuming
Solution Approach 1:
The stitching process is segmented into standardized, repetitive patterns that can be efficiently executed. The leaflets are attached using systematic stitch sequences that divide the complex attachment task into manageable segments, reducing overall process complexity while ensuring complete and reliable structural integrity.
Solution Approach 2:
The stitching parameters such as stitch density, stitch pattern, and thread tension are optimized to achieve the minimum required structural integrity with the simplest possible process. By carefully selecting and standardizing these parameters, the manufacturing complexity is reduced while maintaining the necessary reliability of the valve assembly.
Data Source
AI summary
A replacement heart valve and stitching method for reducing the unexpanded profile of the replacement heart valve are herein provided. The method includes whip stitching a plurality of leaflets together with a first whip stitch pattern a second whip stitch pattern which overlaps the first whip stitch pattern and is wound in an opposite direction. The method further involves securing the valve leaflets to one another via a running stitch.