Prosthetic Heart Valve Suturing Fixture With Projected Stitch Guidance

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Solution Overview

Problem

The manufacturing of prosthetic heart valves requires precise and labor-intensive suturing operations, which can lead to operator strain and potential errors due to the complexity and precision needed, especially when performing small stitches, and existing methods often require dual-hand operations that can cause ergonomic issues and increase the risk of injury.

Innovation Solution

A method utilizing an automated fixture with a vision assist system that positions a prosthetic heart valve and projects visual indicators on its surface to guide the operator for accurate stitching, reducing physical strain and improving precision by allowing single-hand operation and automating the positioning of the valve during the suturing process.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If automated positioning and visual guidance systems are implemented, then manufacturing precision and operator safety are improved, but device complexity and initial cost increase

Engineering Contradiction:
Improvesuturing precisionVSAvoidfixture complexity
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The patent replaces manual mechanical positioning and visual estimation with an automated fixture system that uses vision assist technology (cameras, image processing) and automated actuators to position the heart valve and guide suturing. This substitution of manual mechanical operations with automated systems directly improves precision while accepting increased device complexity as a necessary trade-off.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The vision assist system creates digital copies or representations of the heart valve geometry and suturing positions through imaging and image processing. These digital models are then used to guide the automated positioning and suturing operations, allowing for precise replication of intended suturing patterns without requiring complex manual measurement and calculation.

Inventive Principle:
Principle #26Copying

2Ease of operation

If dual-hand operations are required for manual suturing, then flexibility and manual control are maintained, but operator strain and injury risk increase

Engineering Contradiction:
Improveoperator ergonomicsVSAvoidoperator safety
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The automated fixture system performs the positioning and guidance functions that would otherwise require operator effort and coordination. The system serves itself by automatically positioning the heart valve, providing visual guidance, and guiding the suturing needle placement, freeing the operator from strenuous dual-hand coordination tasks and reducing physical strain while maintaining or improving operational reliability.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The automated fixture acts as an intermediary between the operator and the heart valve suturing process. It mediates the complex coordination required for dual-hand operations by handling positioning and guidance functions, allowing the operator to focus on the suturing action itself with reduced physical strain and improved safety.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Productivity

If manual positioning and visual estimation are used, then device complexity is minimized, but manufacturing precision and efficiency decrease

Engineering Contradiction:
Improvemanufacturing efficiencyVSAvoidsystem complexity
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The patent replaces manual visual estimation and positioning with an automated vision assist system that uses cameras, image processing algorithms, and automated actuators. This substitution dramatically improves manufacturing efficiency by enabling faster, more accurate positioning and guidance, while the increased device complexity is accepted as necessary to achieve the productivity gains.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The vision assist system creates digital representations of the heart valve and suturing targets, allowing for rapid calculation and communication of precise positioning information. This digital copying and processing enables faster decision-making and more efficient operations compared to manual visual estimation, justifying the increased system complexity.

Inventive Principle:
Principle #26Copying

Data Source

PatentUS20220241069A1Heart valve manufacturing devices and methods
Publication Date: 2022.08.04 EDWARDS LIFESCIENCES CORP
  • US20220241069A1 patent drawing
  • US20220241069A1 patent drawing
  • US20220241069A1 patent drawing

AI summary

A suturing assistance system that can be used for prosthetic heart valve manufacturing or suturing procedures. The assistance system includes an automated fixture that includes an articulating arm and a target device holder. The system also includes a vision assist system that projects a visual indicator on the surface of the target device to indicate the location of the next suture to be formed or inspected. The assistance system can include a visualization system configured to display operating procedures to an operator. The visual indicator can guide the operator in performing a sequence of steps to manufacture or inspect a target device. Properties of the visual indicator, such as color and/or shape, can be adjusted or tailored to convey information to the operator during the procedure.