Frozen Tissue Sectioning for Bioprosthetic Thickness Control

Resolve Bottlenecks,
Find Innovative Solutions
Generate Solutions

Solution Overview

Problem

Current methods for preparing bioprosthetic devices, such as heart valves, face challenges in consistently producing tissue swatches of uniform or varying thicknesses, which is crucial for optimal performance and durability in cardiovascular applications.

Innovation Solution

A method involving the use of a cryocutting apparatus to section frozen tissue sheets into desired thicknesses, employing straight or contoured blades and specimen disks with flat or contoured surfaces, allowing for the production of tissue swatches with specific thicknesses ranging from 0.001 to 0.050 inches, suitable for various bioprosthetic devices.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Length of moving object

If compression based techniques are used to reduce tissue thickness, then tissue thickness is reduced, but manufacturing precision and consistency of thickness are poor

Engineering Contradiction:
Improvetissue thicknessVSAvoidthickness uniformity
Core Design Contradiction:
Length of moving objectVSManufacturing precision

Solution Approach 1:

The patent replaces mechanical compression methods with a cryotome-based freezing and slicing system. The cryotome uses a freezing blade to freeze tissue sections at controlled temperatures (-70°C to -20°C) while simultaneously slicing them to precise thicknesses, eliminating the need for mechanical compression and achieving both thickness reduction and uniformity.

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

Solution Approach 2:

The patent changes the physical state of the tissue from fresh to frozen during processing. By controlling the freezing temperature and duration, the tissue maintains its structural integrity while allowing precise thickness control during slicing. The freezing parameter enables consistent thickness achievement that mechanical compression cannot provide.

Inventive Principle:
Principle #35Parameter changes

2Length of moving object

If lasers or mechanical devices are used to reduce tissue thickness, then tissue thickness is reduced, but tissue damage and shear forces increase

Engineering Contradiction:
Improvetissue thicknessVSAvoidtissue damage
Core Design Contradiction:
Length of moving objectVSObject-affected harmful factors

Solution Approach 1:

The patent replaces laser and aggressive mechanical cutting methods with a controlled freezing and slicing process. The cryotome blade slices frozen tissue gently, minimizing shear forces and tissue damage compared to thermal or high-mechanical-force methods.

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

Solution Approach 2:

The tissue is frozen in advance before slicing, which prepares it for gentle, controlled cutting. The freezing step stiffens the tissue structure, allowing the blade to slice through with minimal resistance and reduced shear forces, thereby preventing tissue damage during thickness reduction.

Inventive Principle:
Principle #10Preliminary action

3Productivity

If conventional processing methods are used, then processing speed is maintained, but productivity and efficiency are limited

Engineering Contradiction:
Improveprocessing efficiencyVSAvoidprocessing time
Core Design Contradiction:
ProductivityVSLoss of time

Solution Approach 1:

The patent merges the freezing and slicing operations into a single integrated cryotome process. The tissue is frozen and sliced simultaneously in one operation, eliminating separate processing steps and significantly improving efficiency compared to conventional sequential methods.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The cryotome process maintains continuous freezing and slicing action without interruption. The tissue remains frozen throughout the slicing process, allowing uninterrupted production of uniform sections, which increases productivity and reduces overall processing time compared to conventional methods that require multiple steps.

Inventive Principle:
Principle #20Continuity of useful action

4Manufacturing precision

If tissue is sectioned to very thin sections, then precision for minimally invasive procedures is achieved, but manufacturing complexity increases

Engineering Contradiction:
Improvesection thickness precisionVSAvoidsectioning apparatus complexity
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The patent uses a cryotome with a freezing blade instead of complex mechanical sectioning devices. The freezing mechanism simplifies the overall system while enabling precise thin sectioning. The blade freezes and slices the tissue in a single motion, achieving high precision without requiring complex mechanical adjustment systems.

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

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 approach enables the creation of tissue swatches with precise thicknesses, enhancing the durability and performance of bioprosthetic devices, particularly in cardiovascular applications, by reducing shear damage and facilitating minimally invasive procedures while minimizing waste and production costs.

Implementation Method 1

sectioning a sheet of frozen tissue

Methodology Applied
Scientific EffectFreezing: Freezing

Implementation Method 2

sectioning a sheet of frozen tissue to produce a tissue swatch of said one or more desired thicknesses

Methodology Applied
Scientific EffectMechanical cutting: Mechanical Force

Data Source

PatentUS10653520B2Method of preparing a tissue swatch for a bioprosthetic device
Publication Date: 2020.05.19 ST JUDE MEDICAL CARDILOGY DIV INC
  • US10653520B2 patent drawing
  • US10653520B2 patent drawing
  • US10653520B2 patent drawing

AI summary

A method of preparing a tissue swatch comprising one or more desired thicknesses for use in the manufacture of a bioprosthetic device, the method comprising sectioning a sheet of frozen tissue to produce a tissue swatch of the one or more desired thicknesses.