Spongy Biological Material Drying Process for TAVI Implants

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Solution Overview

Problem

Existing biological materials for medical applications, such as those used to seal and stop blood flow, face challenges including limited flexibility, irreversible damage from drying, and unsatisfactory long-term durability, which hinder their effectiveness in applications like TAVI procedures.

Innovation Solution

A method for preparing porous biological materials involves exposing the material to a first liquid with a component other than water, applying repeated compression forces, and drying the material. This process includes alternating compression and relaxation intervals to enhance the penetration and saturation of the liquid, leading to improved stabilization and flexibility.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stability of the object's composition

If conventional drying procedures are applied to biological materials, then the materials can be stored dry with reduced dimensions, but the materials suffer irreversible damage and lose flexibility

Engineering Contradiction:

Improvestorage stabilityVSAvoidflexibility

Core Design Contradiction:

Stability of the object's compositionVSEase of operation

Solution Approach 1:

The biological material is pre-treated with a stabilization liquid containing stabilizing agents (such as sugars, polyols, or proteins) before drying. This preliminary action protects the material's structural integrity and flexibility during the subsequent drying process, preventing irreversible damage while maintaining storage stability.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The drying process parameters are modified by controlling humidity, temperature, and drying rate to prevent excessive water removal that causes brittleness. The material is dried to a controlled moisture content that maintains flexibility while achieving storage stability, rather than complete drying.

Inventive Principle:

Principle #35Parameter changes

2Stability of the object's composition

If conventional drying procedures are applied to biological materials, then the materials can be stored dry, but the materials become brittle and lose their functional properties

Engineering Contradiction:

Improvestorage stabilityVSAvoidfunctional durability

Core Design Contradiction:

Stability of the object's compositionVSReliability

Solution Approach 1:

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

A stabilization liquid acts as an intermediary substance that penetrates the material's porous structure and provides protective effects during drying. The stabilizing agents in this liquid form protective complexes with the material's structural components, preventing denaturation and maintaining functional properties throughout storage.

Inventive Principle:

Principle #24Intermediary (Mediator)

3Stability of the object's composition

If stabilization liquid is applied to sponge-like material, then the material can be stabilized, but the liquid only penetrates the outside and not the center portion

Engineering Contradiction:

Improvematerial stabilizationVSAvoiduniform penetration

Core Design Contradiction:

Stability of the object's compositionVSManufacturing precision

Solution Approach 1:

The stabilization liquid is applied in multiple periodic cycles rather than a single continuous application. Between applications, the material is allowed to partially equilibrate, enabling the liquid to progressively penetrate deeper into the porous structure and achieve more uniform distribution throughout the material, including the center portion.

Inventive Principle:

Principle #19Periodic action

Solution Approach 2:

The material is pre-treated or pre-conditioned (e.g., by partial drying or structural modification) before applying the stabilization liquid. This preliminary action opens up the porous structure or increases surface area, facilitating better penetration and more uniform distribution of the stabilization liquid throughout the material.

Inventive Principle:

Principle #10Preliminary action

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 results in a biological material with reduced dimensions that can be stored dry, yet expands significantly upon contact with liquids like blood, effectively sealing leaks and providing long-term durability suitable for applications like TAVI, while maintaining biocompatibility.

Implementation Method 1

enhance the penetration and saturation of the liquid

Methodology Applied

Scientific EffectAbsorption: Absorption (physical)

Implementation Method 2

penetration and saturation of the liquid

Methodology Applied

Scientific EffectCapillary action: Capillary Action

Implementation Method 3

expands significantly upon contact with liquids like blood

Methodology Applied

Scientific EffectSwelling:

Data Source

PatentUS20250186658A1Process for preparing a dried, swellable, spongy biological material for implants

Publication Date: 2025.06.12 BIOTRONIK AG

AI summary

A method for preparing a biological material for a medical application includes exposing the biological material to a first liquid, for example including, by at least 10%, a component other than water, and applying a first compression step onto the biological material, wherein the first compression step includes repeatedly applying a compression force in a plurality of compression intervals. The method further includes drying the biological material, and can included applying second and/or third liquids after respective first and second compression steps.