Automated Pericardial Tissue Thickness Measurement and Cutting

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Solution Overview

Problem

The existing process for preparing pericardial tissue for prosthetic heart valves is time-consuming and dependent on manual skill, leading to inconsistent leaflet thickness and inefficiency, particularly for smaller valves where uneven leaflets can detrimentally affect valve functioning.

Innovation Solution

A system and method utilizing a die-cut assembly with a thickness gauge and shield to automate the measurement and cutting of pericardial tissue, ensuring uniform thickness and minimizing tissue damage, by positioning a die with a plate, die pattern, and opening over the tissue, allowing for automated vertical and horizontal movement and precise cutting.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If manual thickness measurement and leaflet selection process is used, then flexibility in handling tissue is maintained, but the process becomes time-consuming and quality is dependent on technician skill

Engineering Contradiction:

ImproveManual handling flexibilityVSAvoidProcessing speed

Core Design Contradiction:

Ease of operationVSProductivity

Solution Approach 1:

The system enables self-service automation where the automated thickness measurement and mapping system operates independently to identify suitable tissue regions and guide the cutting process, reducing reliance on manual technician intervention while maintaining operational flexibility

Inventive Principle:

Principle #25Self-service

Solution Approach 2:

The patent replaces manual mechanical measurement processes with an automated optical thickness measurement system that uses light transmission through the tissue to determine thickness, eliminating the need for manual contact measurement and significantly increasing processing speed

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

2Reliability

If manual thickness measurement and sorting is performed, then tissue can be handled with care, but the process is time-consuming and labor-intensive

Engineering Contradiction:

ImproveTissue handling qualityVSAvoidMeasurement and sorting time

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The system performs preliminary thickness measurement and mapping of the entire tissue section before cutting begins. This advance mapping identifies all suitable regions for leaflet fabrication, allowing the cutting process to proceed efficiently without repeated measurement interruptions

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The automated thickness measurement system serves multiple functions: it maps the entire tissue section, identifies suitable regions for cutting, guides the cutting process, and provides data for quality control, replacing multiple separate manual operations with a single multi-functional system

Inventive Principle:

Principle #6Universality (Multi-functionality)

3Productivity

If automated thickness measurement system is implemented, then processing speed increases, but device complexity increases

Engineering Contradiction:

ImproveProcessing speedVSAvoidMeasurement and cutting system complexity

Core Design Contradiction:

ProductivityVSDevice complexity

Solution Approach 1:

The patent combines the thickness measurement system, tissue mapping software, and cutting guidance system into an integrated automated platform. This merging of functions reduces the need for separate devices and simplifies the overall system architecture while maintaining high processing speed

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The system creates a digital map (copy) of the tissue thickness distribution that can be stored, analyzed, and used to guide the cutting process without requiring physical re-measurement. This digital copying eliminates repeated measurement operations and simplifies the control system

Inventive Principle:

Principle #26Copying

4Manufacturing precision

If manual leaflet die-cutting is performed, then precision depends on technician skill, but the process remains flexible and adaptable

Engineering Contradiction:

ImproveLeaflet thickness uniformityVSAvoidCutting system automation level

Core Design Contradiction:

Manufacturing precisionVSDevice complexity

Solution Approach 1:

The automated cutting system uses real-time feedback from the thickness measurement data to adjust cutting parameters and guide the die-cutting process. The system continuously monitors tissue thickness and adjusts the cutting depth and position to ensure uniform leaflet thickness, achieving precision without requiring high technician skill

Inventive Principle:

Principle #23Feedback

Data Source

PatentUS11517427B2Systems for assessing and cutting bioprosthetic tissue

Publication Date: 2022.12.06 EDWARDS LIFESCIENCES CORP

AI summary

Systems, dies, and methods are provided for processing pericardial tissue. The method includes positioning a die-cut assembly over the pericardial tissue, the die-cut assembly including a die having a plate, a die pattern, and an opening, the die pattern attached to the plate, the opening formed in the plate to provide access to the pericardial tissue, and measuring a thickness of the tissue through the opening. The die-cut assembly may be mounted for automated vertical movement, and a platen on which the tissue is placed is capable of automated horizontal movement. Different target areas on the tissue can be assessed by measuring the thickness through the die, and when an area is deemed suitable the die pattern cuts a shape therefrom. The system is useful for cutting uniform thickness heart valve leaflets, and can be automated to speed up the process.