Disposable Scaffold for Cardiac Valve Leaflet Assembly
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Solution Overview
Problem
Current methods for reconstructing and implanting aortic valve leaflets are tedious and time-consuming, involving manual assembly and sizing, which can be improved for efficiency and reduced surgery time.
Innovation Solution
A disposable temporary scaffold/fixture is provided, made from injected molded polymer or metal, which holds individual leaflets in place for pre-assembly and can utilize a vacuum system to aid in stitching, allowing for simplified leaflet installation and later removal from the patient.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If manual assembly and sizing of valve leaflets is performed, then surgical precision can be achieved, but surgery time and procedural complexity increase significantly
Solution Approach 1:
The scaffold is pre-configured with positioning features, measurement markers, and alignment guides before the surgical procedure. This allows the surgeon to simply place the leaflets onto the pre-prepared scaffold rather than performing complex measurements and assembly steps during surgery, thereby reducing surgery time while maintaining precision through the pre-engineered scaffold geometry
Solution Approach 2:
The scaffold acts as an intermediary device between the individual valve leaflets and the final implanted valve structure. It provides a temporary framework that holds multiple leaflets in the correct spatial relationship, enabling precise assembly without requiring the surgeon to manually measure and position each leaflet individually during the procedure
2Reliability
If individual leaflets are manually stitched to the aorta wall, then secure implantation is achieved, but the procedure becomes tedious and time-consuming
Solution Approach 1:
The scaffold combines multiple functional elements into a single integrated structure: it holds multiple leaflets simultaneously, provides alignment guidance, and facilitates suturing through its design features. This merging of functions allows the surgeon to work with a unified structure rather than individually positioning and securing each leaflet separately, thereby improving assembly efficiency while maintaining implantation security
Solution Approach 2:
The scaffold serves as a temporary intermediary structure that holds the leaflets in the correct configuration during assembly and implantation. It provides mechanical support and positioning guidance throughout the procedure, making the stitching process more efficient while ensuring reliable implantation. The scaffold is removed after the leaflets are securely attached to the aorta wall
3Productivity
If a temporary scaffold is introduced to hold leaflets, then assembly efficiency improves, but device complexity increases
Solution Approach 1:
The scaffold is designed as a segmented or modular structure with distinct functional zones: leaflet holding regions, alignment guide features, and removal mechanisms. This segmentation allows each portion of the scaffold to perform a specific function efficiently while keeping the overall design relatively simple and manageable, thereby improving assembly speed without excessive complexity
Solution Approach 2:
The scaffold is designed as a disposable device that is discarded after a single use. This allows for optimization of the scaffold's structure and functionality without concern for long-term durability or reusability, enabling the use of relatively simple materials and designs that can be manufactured cost-effectively while providing the necessary assembly assistance during surgery
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
The scaffold facilitates faster and more efficient assembly of valve leaflets, reducing surgery time and complexity by providing a tool to hold leaflets in place during stitching and subsequent implantation, while also enabling precise cutting and sizing of leaflets using specialized cutting tools.
Implementation Method 1
The device can utilize a vacuum system to help hold the leaflets when a tube construction was used
Data Source
AI summary
A device for joining individual leaflets for repairing a cardiac valve of a patient has a base and projection fingers rising from the base to support adjacent leaflets for tacking together by sewing overlapping edges of adjacent leaflets prior to emplacement into the patient. The invention provides a cutting tool for excising leaflets from a pericardial tissue sheet according to predetermined sizes and shapes. A leaflet having a desired contour and size is obtained by pressing the tool formed as a cutter block against the tissue sheet. A set of blocks can be provided wherein each cutter block has an outer edge following a respective contour and size for a leaflet, and wherein the outer edge includes a raised cutting edge for pressing through the pericardial tissue sheet. The blocks can be held in a press for assisting in pushing the cutting edge through the tissue.