Heart Valve Crimping Profile Using Segmented Jaw Compression
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current crimping devices for prosthetic heart valves apply uniform crimping forces across the entire valve, leading to undesirable shape properties that can result in the device catching on sheaths or vessels during delivery, potentially causing adverse events.
Innovation Solution
The use of crimping devices with multiple sets of side-by-side jaws that can close to different inner diameters allows for targeted compression of specific valve sections, enabling a more controlled crimping process with multi-stage positioning of the valve relative to the jaws to achieve a desirable crimped profile that protects the leading edge and aids insertion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If uniform crimping forces are applied across the entire valve using a single continuous jaw face, then the valve is compressed equally along its length to a smaller diameter, but the valve develops undesirable shape properties that can cause it to catch on sheaths or vessels during delivery
Solution Approach 1:
The single continuous jaw face is divided into multiple separate jaw segments (first jaw, second jaw, third jaw, fourth jaw) that can be independently controlled. This segmentation allows different axial portions of the valve to receive different crimping forces, enabling creation of a tailored crimped profile with varying compression levels along the valve length, thus preventing catching on sheaths or vessels while maintaining manufacturing feasibility
Solution Approach 2:
Different jaw segments apply different crimping forces to different axial portions of the valve. The first and second jaws apply a first crimping force to a first axial portion, while the third and fourth jaws apply a second crimping force to a second axial portion. This local differentiation of crimping quality creates an optimized profile where specific sections have different compression characteristics, preventing uniform deformation that causes catching issues
2Manufacturing precision
If the entire valve is positioned within the jaws during crimping, then crimping forces are applied uniformly across the axial length, but this results in non-uniform compression that can cause adverse events during delivery
Solution Approach 1:
The valve is divided into different axial portions (first axial portion and second axial portion) that are crimped by different jaw segments. This segmentation allows controlled non-uniform compression where different sections experience different forces, creating a profile that maintains manufacturing precision while improving delivery safety by preventing catching on anatomical structures
Solution Approach 2:
Different axial portions of the valve receive different crimping forces tailored to their specific requirements. The first axial portion receives a first crimping force while the second axial portion receives a second crimping force, creating localized quality variations that optimize both the crimped profile and delivery characteristics, thereby improving reliability without sacrificing manufacturing precision
3Adaptability or versatility
If multiple sets of side-by-side jaws with different inner diameters are used, then different parts of the valve can be compressed to different outer diameters, but the device complexity increases
Solution Approach 1:
The crimping device uses multiple separate jaw segments (first jaw, second jaw, third jaw, fourth jaw) arranged in pairs, where each pair can be independently controlled. This segmentation provides adaptability to create different crimping profiles by selectively actuating different jaw pairs, while the modular segmented structure keeps the overall device complexity manageable through standardized components
Solution Approach 2:
Multiple jaw segments are combined within a single crimping device structure, allowing different parts of the valve to be compressed to different outer diameters simultaneously. The first and second jaws work together on the first axial portion while the third and fourth jaws work on the second axial portion, merging multiple crimping functions into one integrated device that achieves versatile profile control without requiring separate devices
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
This method ensures a more uniform and controlled crimped profile, reducing the likelihood of the valve catching on anatomical structures during delivery and improving the device's ability to pass through the anatomy successfully.
Implementation Method 1
closing and opening the jaws with the valve and delivery device in the first axial position, such that the valve is at least partially crimped onto the balloon between the proximal shoulder and the distal shoulder
Data Source
Figure 1A~2
Figure 3~4
Figure 5~6
AI summary
Devices and methods for crimping a prosthetic heart valve onto a delivery device are described. In some embodiments, valves are crimped over an inflatable balloon and between proximal and distal shoulders mounted on a shaft inside the balloon. Crimping methods can include multiple compression steps with the valve located in different axial positions relative to the crimping jaws at each different step. In some methods, the valve may extend partially outside of the crimping jaws during certain crimping steps, such that the crimping force is only applied to the part of the valve that is inside the jaws. Exemplary crimping devices can include two or more adjacent sets of jaws that close down to different inner diameters, such that different parts of a valve get compressed to different outer diameters at the same time during a single crimping step.