Biodegradable Microneedle Anchoring for ECM Tissue Regeneration

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Solution Overview

Problem

Conventional ECM-based tissue repair devices face issues with non-biodegradable securing structures that cause irritation and adverse biologic responses, and are prone to failure, especially in cardiovascular applications where they may lead to vascular thrombosis due to inadequate contact with the vessel wall.

Innovation Solution

Biocompatible and biodegradable ECM constructs with a support scaffold and microneedle anchoring members that securely attach to tissue, allowing for effective tissue regeneration and administration of pharmacological agents, while minimizing adverse reactions by using biodegradable materials like stainless steel and magnesium, and incorporating ECM materials from various mammalian sources.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If non-biodegradable securing structures are used to secure the apparatus to tissue, then the apparatus can be securely anchored, but the structures cause irritation and undesirable biologic responses in the surrounding tissue

Engineering Contradiction:

Improvesecuring effectivenessVSAvoidtissue irritation and adverse biologic responses

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent changes the material parameter of the securing structures from non-biodegradable to biodegradable materials. The microneedles are made of biocompatible and biodegradable materials that degrade over time, eliminating the long-term irritation and adverse biologic responses while maintaining secure anchoring during the critical healing period.

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The microneedles are designed as temporary, short-living securing structures that fulfill their anchoring function during the initial healing phase and then degrade naturally in the body, eliminating the need for permanent foreign materials that cause ongoing tissue irritation.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

2Reliability

If non-biodegradable securing structures are used, then the apparatus can be securely anchored, but the structures are prone to failure resulting in severe adverse consequences

Engineering Contradiction:

Improvesecuring effectivenessVSAvoidstructure failure and severe adverse consequences

Core Design Contradiction:

ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The patent changes the material properties of the securing structures to use biocompatible and biodegradable materials with optimized mechanical properties. These materials provide sufficient strength during the critical anchoring period while degrading safely without causing structure failure or severe adverse consequences.

Inventive Principle:

Principle #35Parameter changes

3Ease of operation

If the endograft is not placed in intimate contact with the vessel wall, then deployment is easier, but blood pools between the endograft and vessel wall causing vascular thrombosis

Engineering Contradiction:

Improvedeployment easeVSAvoidblood pooling and vascular thrombosis

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The patent divides the securing function into multiple microneedles distributed across the endograft surface. This segmentation allows the endograft to be deployed more easily while the distributed microneedles ensure intimate contact with the vessel wall at multiple points, preventing blood pooling and thrombosis formation.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The microneedles act as intermediary elements between the endograft and the vessel wall, facilitating intimate contact and securing the endograft in place without requiring complex deployment mechanisms, thereby preventing blood pooling while maintaining ease of deployment.

Inventive Principle:

Principle #24Intermediary (Mediator)

4Object-affected harmful factors

If biodegradable materials are used for the support scaffold and anchoring members, then adverse biologic responses are reduced, but the duration of securing may be insufficient

Engineering Contradiction:

Improveadverse biologic responsesVSAvoidsecuring duration

Core Design Contradiction:

Object-affected harmful factorsVSDuration of action of stationary object

Solution Approach 1:

The patent optimizes the degradation parameters of the biodegradable materials used in microneedles and support scaffold. The materials are engineered to degrade at controlled rates that match the tissue healing timeline, providing sufficient securing duration during the critical healing period while minimizing adverse biologic responses through biocompatibility.

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The biodegradable materials maintain their structural integrity and securing function continuously during the healing process, gradually degrading as tissue regeneration progresses. This ensures continuous useful action for anchoring throughout the critical healing period without causing adverse responses.

Inventive Principle:

Principle #20Continuity of useful action

Data Source

PatentUS8778012B2ECM constructs for tissue regeneration

Publication Date: 2014.07.15 CORVIVO CARDIOVASCULAR INC

AI summary

An extracellular matrix (ECM) construct having a biodegradable support scaffold that includes a plurality of biodegradable microneedles that are capable of piercing tissue and anchoring therein, and at least a first layer of first ECM material disposed on the top surface of the support scaffold.