Tissue Modification Device for Heart Valve Mechanical Property Consistency

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Solution Overview

Problem

The variation in mechanical properties of biological tissue used in replacement heart valves can impact their performance and durability, leading to inconsistent results in heart valve surgery.

Innovation Solution

A tissue modification method and apparatus that applies equal tension to inconsistent biological tissue using grippers and force actuators, followed by chemical cross-linking to stabilize the tissue, ensuring consistent mechanical properties.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If biological tissue is used for replacement heart valves, then the biological compatibility is improved, but the mechanical property consistency deteriorates due to non-uniform thickness and donor variation

Engineering Contradiction:
Improvebiological compatibilityVSAvoidmechanical property consistency
Core Design Contradiction:
ReliabilityVSManufacturing precision

Solution Approach 1:

The tissue is stretched and tensioned before implantation to pre-adjust its mechanical properties. The stretching apparatus applies controlled tension to the tissue in advance, ensuring consistent mechanical properties before the tissue is used in the heart valve, thereby resolving the inconsistency issue while maintaining biological compatibility

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The mechanical properties of the tissue are modified by changing physical parameters during the stretching process. By applying controlled tension and adjusting stretching parameters, the tissue's mechanical properties are standardized to ensure consistency across different donors and tissue samples

Inventive Principle:
Principle #35Parameter changes

2Manufacturing precision

If tension is applied to stretch biological tissue, then the mechanical property consistency is improved, but the tissue structure may be damaged

Engineering Contradiction:
Improvemechanical property consistencyVSAvoidtissue structural integrity
Core Design Contradiction:
Manufacturing precisionVSStrength

Solution Approach 1:

The stretching apparatus uses dynamic, adjustable tension application rather than static force. The system can adapt the stretching force and duration based on tissue response, allowing consistent mechanical properties to be achieved while minimizing structural damage through controlled, progressive tension

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The system incorporates feedback mechanisms to monitor tissue response during stretching. By detecting tissue mechanical response in real-time, the apparatus can adjust tension levels to achieve desired mechanical consistency without exceeding thresholds that would cause structural damage

Inventive Principle:
Principle #23Feedback

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 method provides reliable and consistent mechanical properties for biological tissues, enhancing the performance and durability of prosthetic heart valves by standardizing tissue tension and cross-linking.

Implementation Method 1

contacting the patch of tissue with a cross-linking chemical while secured to the frame and under tension to cross-link the patch while under tension

Methodology Applied
Scientific EffectCross-linking: Chemical Bonding

Data Source

PatentEP3344786B1Tissue modification devices, systems, and methods
Publication Date: 2023.08.23 BOSTON SCIENTIFIC SCIMED INC
  • EP3344786B1 patent drawingFigure 1A~1B
  • EP3344786B1 patent drawingFigure 2
  • EP3344786B1 patent drawingFigure 3

AI summary

A tissue modification apparatus includes at least a first plurality of grippers aligned in a plane adapted to secure a first edge of a patch of tissue. The plurality of grippers are each secured to a first force actuator. The first plurality of grippers are each adapted to pivot relative to the first force actuator about an axis perpendicular to the plane. In some cases, a plurality of grippers are attached to a force actuator by a passive force transfer mechanism. In some cases, individual force actuators are attached by pivoted connections to individual grippers. Methods of treating tissue can secure tensioned tissue to a frame to retain the tension during a treatment (e.g., cross-linking the tissue with a chemical cross-linker).