Bilayer Cardiac Patch Structure for LV Remodeling and Tissue Integration

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Solution Overview

Problem

Existing treatments for ischemic cardiomyopathy, such as drug therapies and surgical procedures, fail to effectively prevent left ventricular (LV) remodeling and dilation, while cell-based therapies show minimal clinical benefit, and existing cardiac patches lack adequate mechanical support and promote encapsulation as a foreign body, hindering tissue functional recovery.

Innovation Solution

A bi-layer cardiac patch comprising a first layer of anisotropic synthetic, biocompatible, bioerodible fibers and a second layer of acid protease-solubilized extracellular matrix (ECM) fibers, which provides mechanical support and a conducive microenvironment for host cell recruitment, mimicking native cardiac mechanics.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If a biodegradable cardiac patch is applied to provide temporary mechanical support, then LV remodeling is mitigated, but the patch may be encapsulated as a foreign body, hindering tissue functional recovery

Engineering Contradiction:

Improvemechanical supportVSAvoidforeign body encapsulation

Core Design Contradiction:

StrengthVSObject-generated harmful factors

Solution Approach 1:

The cardiac patch combines synthetic biodegradable polymer fibers (providing mechanical strength) with natural extracellular matrix (ECM) components (promoting cell integration). This composite structure allows the patch to provide necessary mechanical support while simultaneously encouraging host tissue integration and reducing foreign body response through the bioactive ECM layer.

Inventive Principle:

Principle #40Composite materials

Solution Approach 2:

The patch utilizes controlled degradation of the synthetic polymer component over time, transitioning from a mechanically dominant structure to a gradually disappearing scaffold. This temporal parameter change allows the patch to provide mechanical support when needed, then progressively integrate with host tissue as the synthetic component degrades and is replaced by native ECM.

Inventive Principle:

Principle #35Parameter changes

2Stability of the object's composition

If existing cardiac patches are used to provide mechanical support, then LV dilation is reduced, but they lack adequate mechanical support and promote encapsulation

Engineering Contradiction:

ImproveLV structural stabilityVSAvoidmechanical support adequacy

Core Design Contradiction:

Stability of the object's compositionVSStrength

Solution Approach 1:

The patch combines synthetic biodegradable polymer fibers (providing mechanical strength) with natural extracellular matrix (ECM) components (promoting cell integration). This composite structure allows the patch to provide necessary mechanical support while simultaneously encouraging host tissue integration and reducing foreign body response through the bioactive ECM layer.

Inventive Principle:

Principle #40Composite materials

3Reliability

If cell injection-based therapies are used to treat the initial stage, then regenerative activity is promoted, but the clinical benefit is minimal

Engineering Contradiction:

Improveregenerative activityVSAvoidclinical benefit

Core Design Contradiction:

ReliabilityVSProductivity

Solution Approach 1:

The ECM-containing patch serves as an intermediary scaffold that facilitates natural host cell recruitment and tissue regeneration rather than relying on injected cells. The bioactive ECM components create a conducive microenvironment that attracts and supports endogenous cell migration, proliferation, and differentiation, leading to more reliable clinical outcomes.

Inventive Principle:

Principle #24Intermediary (Mediator)

4Stability of the object's composition

If epicardial restraint devices are used to provide physical block of continued cardiac dilatation, then LV remodeling is prevented, but the heart is encapsulated in a permanent foreign body

Engineering Contradiction:

Improvecardiac dilatation preventionVSAvoidpermanent foreign body presence

Core Design Contradiction:

Stability of the object's compositionVSDuration of action of stationary object

Solution Approach 1:

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 bi-layer patch mitigates LV wall thinning, reduces scar formation, promotes host cell infiltration, and improves cardiac function by recapitulating native mechanics and providing a supportive microenvironment, potentially reducing post-infarction mortality.

Implementation Method 1

a second layer comprising acid protease-solubilized ECM dispersed throughout the network of synthetic, biocompatible fibers of the second layer

Methodology Applied

Scientific EffectAcid protease solubilization: Enzyme

Implementation Method 2

the layers are fibrous electrospun layers

Methodology Applied

Scientific EffectElectrospinning: Electrohydrodynamics

Data Source

PatentEP3347063B1Bi-layer extra cellular matrix scaffolds and uses therefor

Publication Date: 2025.11.19 UNIV OF PITTSBURGH OF THE COMMONWEALTH SYST OF HIGHER EDUCATION

Figure 1A~1B
Figure 2A~2E
Figure 3A~3H

AI summary

Provided herein is a bilayer medical device (e.g., "patch") for use in treating ischemic cardiomyopathy as well as for treatment of other conditions. The medical device comprises a first, support layer and a second, ECM-containing layer over the first layer. Methods of making and using the device also are provided herein.