Dry-Stored Bioprosthetic Valved Conduit with Bioresorbable Seal

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Solution Overview

Problem

Current bioprosthetic heart valves and conduits face challenges in storage and deployment due to the need for preserving solutions, which can lead to leakage and increased complexity in the operating room, as well as the risk of infection and prolonged exposure times.

Innovation Solution

A pre-assembled valved conduit with a bioprosthetic heart valve and a tubular conduit sealed with a bioresorbable medium, allowing for dry storage and simplified assembly, using cross-linked bioprosthetic tissue and a desiccant pouch to maintain moisture levels, enabling a hemostatic seal with minimal assembly complexity.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If bioprosthetic heart valves are stored in preserving solutions, then the tissue functionality is maintained, but leakage occurs and assembly complexity increases

Engineering Contradiction:

Improvetissue functionalityVSAvoidassembly complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent removes the preserving solution from the storage system entirely. The bioprosthetic tissue is treated with cross-linking agents and stored in a dry state, extracting the liquid preservative component that caused leakage and assembly complexity while maintaining tissue functionality through chemical stabilization.

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The patent changes the physical state of storage from wet (in preserving solution) to dry. Cross-linking treatment modifies the tissue parameters to allow stable storage in a dry environment, fundamentally changing the storage conditions to eliminate leakage and simplify assembly procedures.

Inventive Principle:

Principle #35Parameter changes

2Reliability

If bioprosthetic heart valves are stored in preserving solutions, then the tissue functionality is maintained, but infection risk increases and exposure time is prolonged

Engineering Contradiction:

Improvetissue functionalityVSAvoidinfection risk

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent extracts the preserving solution from the storage system, removing the medium that could potentially harbor contaminants and extend exposure time. Dry storage eliminates the liquid environment that increases infection risk while cross-linking maintains tissue functionality.

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The tissue undergoes preliminary cross-linking treatment before storage, which stabilizes the tissue structure in advance. This preliminary action allows the tissue to be stored dry without compromising functionality, thereby reducing infection risk and exposure time during storage and handling.

Inventive Principle:

Principle #10Preliminary action

3Device complexity

If conventional bioprosthetic conduits are used, then assembly is simple, but blood leakage through conduit walls occurs

Engineering Contradiction:

Improveassembly simplicityVSAvoidblood leakage

Core Design Contradiction:

Device complexityVSObject-generated harmful factors

Solution Approach 1:

The patent uses a composite structure combining bioprosthetic tissue with a sealing layer or treatment. This composite approach maintains the simplicity of assembly while adding leakage prevention capabilities, as the sealed conduit configuration addresses blood leakage through conduit walls without complicating the assembly process.

Inventive Principle:

Principle #40Composite materials

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 solution allows for the storage of bioprosthetic heart valves without preservative solutions, reducing leakage risks and simplifying the assembly process, thereby shortening implantation time and minimizing infection risks while maintaining the functionality of the bioprosthetic tissue.

Implementation Method 1

using cross-linked bioprosthetic tissue

Methodology Applied

Scientific EffectCross-linking: Chemical Bonding

Implementation Method 2

a desiccant pouch to maintain moisture levels

Methodology Applied

Scientific EffectAbsorption: Absorption (physical)

Implementation Method 3

enabling a hemostatic seal with minimal assembly complexity

Methodology Applied

Scientific EffectHemostasis: Coagulation

Data Source

PatentUS11963869B2Methods of implanting a dry bioprosthetic valved conduit

Publication Date: 2024.04.23 EDWARDS LIFESCIENCES CORP

AI summary

A valved conduit including a bioprosthetic valve, such as a heart valve, and a tubular conduit sealed with a bioresorbable material. The bioprosthetic heart valve includes prosthetic tissue that has been treated such that the tissue may be stored dry for extended periods without degradation of functionality of the valve. The bioprosthetic heart valve may have separate bovine pericardial leaflets or a whole porcine valve. The sealed conduit includes a tubular matrix impregnated with a bioresorbable medium such as gelatin or collagen. The valved conduit is stored dry in packaging in which a desiccant pouch is supplied having a capacity for absorbing moisture within the packaging limited to avoid drying the bioprosthetic tissue out beyond a point where its ability to function in the bioprosthetic heart valve is compromised. The heart valve may be sewn within the sealed conduit or coupled thereto with a snap-fit connection.