Titanium-Coated Biological Heart Valve Prostheses for Calcification Reduction

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Solution Overview

Problem

Biological heart valves, particularly those made from glutaraldehyde-fixed pericardium, suffer from premature calcification due to chemical processes and antigenicity, leading to reduced durability and the need for chronic anticoagulation therapy.

Innovation Solution

A method involving a titanium-containing coating on the biological heart valve prosthesis, followed by irradiation with light of a wavelength between 100 nm and 450 nm, specifically using plasma-activated chemical vapor deposition and UV light, to enhance biocompatibility and reduce structural damage and calcification.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a biological heart valve prosthesis is made from glutaraldehyde-fixed pericardium, then it does not require chronic anticoagulation therapy, but it suffers from premature calcification due to chemical processes and antigenicity

Engineering Contradiction:
Improvedurability of bioprosthetic valveVSAvoidcalcification of valve tissue
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

A titanium-containing coating is applied as an intermediary layer between the glutaraldehyde-fixed pericardium and the biological environment. This coating acts as a barrier that prevents direct interaction between calcification-inducing factors (free aldehyde groups, phospholipids, calcium ions) and the valve tissue, thereby reducing calcification while maintaining the biocompatibility benefits of the biological valve

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent applies UV irradiation (wavelength 100-450 nm) to modify the chemical and physical parameters of the titanium-containing coating. This irradiation process alters the surface properties of the coating, enhancing its ability to resist calcification by changing the reactivity of free aldehyde groups and the overall chemical stability of the coated surface

Inventive Principle:
Principle #35Parameter changes

2Duration of action of stationary object

If a mechanical heart valve is used, then it is durable and may last throughout a patient's life, but patients require blood-thinning medication for the rest of their life

Engineering Contradiction:
Improvelifetime of mechanical valveVSAvoidrisk of bleeding from anticoagulation therapy
Core Design Contradiction:
Duration of action of stationary objectVSObject-generated harmful factors

Solution Approach 1:

The patent applies UV irradiation (wavelength 100-450 nm) to modify the chemical and physical parameters of the titanium-containing coating. This irradiation process alters the surface properties of the coating, enhancing its ability to resist calcification by changing the reactivity of free aldehyde groups and the overall chemical stability of the coated surface

Inventive Principle:
Principle #35Parameter changes

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 significantly reduces calcification by 70% over 9 weeks, allowing for implantation without extra-corporeal circulation and eliminating the need for blood thinners, thereby reducing the risk of internal bleeding.

Implementation Method 1

a) treating the biological heart valve prosthesis with a titanium containing coating

Methodology Applied
Scientific EffectChemical vapor deposition: Chemical Vapour Deposition

Implementation Method 2

plasma-activated chemical vapor deposition

Methodology Applied
Scientific EffectPlasma activation: Plasma

Implementation Method 3

b) irradiating the treated biological heart valve prosthesis with light of a wavelength between 100 nm and 450 nm

Methodology Applied
Scientific EffectUV irradiation: Photopolymerisation

Implementation Method 4

irradiating the treated biological heart valve prosthesis with light of a wavelength between 100 nm and 450 nm, specifically using plasma-activated chemical vapor deposition and UV light

Methodology Applied
Scientific EffectPhoto-oxidation: Photo-oxidation

Data Source

PatentEP4623942A1Method to reduce the calcification of a biological heart valve prosthesis by a titanium containing coating in combination with UV irradiation
Publication Date: 2025.10.01 PFM MEDICAL TITANIUM GMBH
  • EP4623942A1 patent drawing
  • EP4623942A1 patent drawing
  • EP4623942A1 patent drawing

AI summary

The invention relates to a method to reduce the calcification of a biological heart valve prosthesis by a titanium containing coating in combination with UV irradiation. The method for treating the biological heart valve prosthesis with a titanium containing coating, particularly a glutaraldehyde-fixed pericardium, comprising the steps of: a) treating the biological heart valve prosthesis with a titanium containing coating; and b) irradiating the treated biological heart valve prosthesis with light of a wavelength between 100 nm and 450 nm. This results in a biological heart valve prosthesis by a hypothesized polymerization with a homogenous surface.