Prosthetic Heart Valve Coating Reduces Metal Ion Release

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Solution Overview

Problem

Current prosthetic heart valves made from materials like stainless steel, cobalt-chromium alloys, TiNi alloys, and TiAlV alloys face issues such as metal ion release, corrosion, and structural valve disease due to poor hemocompatibility and tissue proliferation.

Innovation Solution

A prosthetic heart valve with a biomedical material frame partially or fully coated with a biocompatible enhancement coating, such as a metal oxynitride layer, to reduce metal ion release, corrosion, and structural valve disease by promoting endothelial cell angiogenesis and reducing inflammatory responses.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If cobalt-chromium alloys or TiNi alloys are used to form the frame of the prosthetic heart valve, then the structural strength and durability are improved, but metal ion release and corrosion occur leading to adverse tissue reactions

Engineering Contradiction:
Improvestructural strengthVSAvoidmetal ion release
Core Design Contradiction:
StrengthVSObject-generated harmful factors

Solution Approach 1:

The patent applies composite materials by combining a metal alloy frame (providing structural strength) with a biocompatible coating layer (reducing metal ion release). The coating layer is deposited over the metal alloy frame to create a composite structure that integrates the advantages of both materials: the metal provides mechanical strength while the coating provides biocompatibility and reduces harmful ion release.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The biocompatible coating acts as an intermediary layer between the metal alloy frame and the surrounding tissue. This intermediate coating prevents direct contact between the metal ions and the tissue, thereby reducing adverse reactions while still allowing the metal frame to provide structural support.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Strength

If metal alloys with chromium and nickel are used for the valve frame, then the mechanical properties are improved, but allergic reactions and tissue failure occur

Engineering Contradiction:
Improvemechanical propertiesVSAvoidallergic reaction
Core Design Contradiction:
StrengthVSObject-affected harmful factors

Solution Approach 1:

The biocompatible coating serves as an intermediary barrier that prevents chromium and nickel ions from the metal alloy from contacting the surrounding tissue. This intermediate layer eliminates the allergic reaction pathway while preserving the mechanical benefits of using chromium and nickel-containing alloys for the frame structure.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent applies local quality by providing a biocompatible coating specifically on the surface portions of the metal alloy frame that are in contact with tissue, while maintaining the metal alloy composition in the bulk frame structure for mechanical strength.

Inventive Principle:
Principle #3Local quality

3Reliability

If a biocompatible coating is applied to reduce metal ion release, then tissue compatibility is improved, but the device complexity increases

Engineering Contradiction:
Improvetissue compatibilityVSAvoiddevice complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent applies parameter changes by modifying the surface properties of the metal alloy frame through coating deposition. This changes the surface composition and chemical properties to be more biocompatible, while the overall device structure and functionality remain relatively simple.

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 enhancement coating significantly reduces metal ion release, corrosion, and structural valve disease, creating a more favorable healing environment and improving the longevity and functionality of the prosthetic heart valve.

Implementation Method 1

metal ion release, corrosion, and structural valve disease due to poor hemocompatibility and tissue proliferation

Methodology Applied
Scientific EffectChemical interaction: Chemical Bonding

Implementation Method 2

promoting endothelial cell angiogenesis and reducing inflammatory responses

Methodology Applied
Scientific EffectAngiogenesis:

Implementation Method 3

reduce metal ion release, corrosion

Methodology Applied
Scientific EffectCorrosion resistance: Oxidation

Data Source

PatentUS20250082468A1Heart valve that includes coating material
Publication Date: 2025.03.13 MIRUS LLC
  • US20250082468A1 patent drawing
  • US20250082468A1 patent drawing
  • US20250082468A1 patent drawing

AI summary

A prosthetic heart valve that is at least partially coated with an enhancement coating, and a method for inserting the prosthetic heart valve in a patient. The prosthetic heart valve includes an expandable frame, a leaflet structure, and optionally an inner skirt and/or an outer skirt. One or more of the components of the prosthetic heart valve can be partially or fully coated with the enhancement coating. One type of enhancement coating that can be used includes titanium oxynitride or titanium nitride oxide (TiNOx) and/or zirconium oxynitride (ZrNxOy).