Expandable ECM Construct Sealing Perivalvular Leaks
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Solution Overview
Problem
Perivalvular leaks often occur during or after cardiovascular valve replacement, posing a significant challenge due to gaps between the replacement valve and the native or calcified valve leaflets, leading to inefficiencies in securing the prosthetic valve and potential complications.
Innovation Solution
A biocompatible, expandable construct made from acellular extracellular matrix (ECM) derived from mammalian small intestine submucosa, which absorbs bodily fluids to expand and seal leaks, potentially incorporating biologically active agents for tissue remodeling and regeneration, and a poly(glycerol sebacate) outer coating for adhesion to cardiovascular tissue.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a prosthetic valve is secured to the native valve annulus using traditional suturing methods, then the valve replacement procedure can be completed, but perivalvular leaks occur due to gaps between the replacement valve and native or calcified valve leaflets
Solution Approach 1:
The patent transforms the sealing mechanism from a rigid mechanical suture-based system to a flexible hydrogel-based system that changes its physical state upon contact with bodily fluids. The hydrogel construct transitions from a compressed delivery state to an expanded sealed state, adapting to the anatomical geometry and achieving conformal contact with the valve annulus and surrounding tissue, thereby eliminating perivalvular leaks without requiring precise suturing.
Solution Approach 2:
The patent employs a composite hydrogel construct comprising crosslinked polymer networks, hydrophilic monomers, and optional biologically active agents. This composite material combines the advantages of flexibility, biocompatibility, and tissue integration capabilities, allowing the seal to adapt to movement and physiological conditions while maintaining effective sealing and promoting tissue regeneration.
2Strength
If traditional suture-based valve attachment is used, then the procedure is straightforward, but the attachment security is compromised due to gaps and potential complications
Solution Approach 1:
The hydrogel construct is designed to self-expand and self-seal upon contact with bodily fluids, eliminating the need for complex mechanical fastening mechanisms or precise surgical suturing. The material autonomously adapts to the anatomical geometry and achieves conformal contact with the valve annulus and surrounding tissue, providing secure attachment through its inherent viscoelastic properties and tissue integration capabilities.
Solution Approach 2:
The patent utilizes the phase transition and swelling behavior of hydrogel materials to achieve secure attachment. The construct transitions from a low-volume compressed state during delivery to a high-volume expanded state in situ, generating radial force against the valve annulus and surrounding tissue. This parameter change enables strong mechanical anchoring without requiring complex external fixation mechanisms.
3Reliability
If rigid sealing structures are used to prevent perivalvular leaks, then sealing may be achieved initially, but adaptability to tissue movement and remodeling is poor
Solution Approach 1:
The patent employs a flexible hydrogel construct that can deform and adapt to tissue movement, cardiac cycling, and physiological changes. The viscoelastic nature of the hydrogel allows it to maintain conformal contact with the dynamic valve annulus and surrounding tissue, ensuring durable sealing that accommodates physiological motion rather than resisting it with rigid structures.
Solution Approach 2:
The hydrogel construct integrates with living tissue through biocompatibility and potential biodegradability, allowing it to remodel and adapt alongside the host tissue over time. The material can degrade and be replaced by native tissue regeneration, ensuring long-term adaptability and eliminating the need for rigid permanent implants that cannot accommodate tissue 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 expandable ECM construct effectively seals perivalvular leaks through initial mechanical abatement and subsequent tissue remodeling, promoting regeneration and enhancing the secure attachment of the prosthetic valve to the cardiovascular tissue, thereby reducing the risk of further leaks and improving surgical outcomes.
Implementation Method 1
A biocompatible, expandable construct made from acellular extracellular matrix (ECM) derived from mammalian small intestine submucosa, which absorbs bodily fluids to expand and seal leaks
Implementation Method 2
a poly(glycerol sebacate) outer coating for adhesion to cardiovascular tissue
Data Source
AI summary
A biocompatible and biodegradable construct comprising a base expandable member and an outer coating comprising poly(glycerol sebacate) (PGS), the base expandable member comprising acellular extracellular matrix (ECM) derived from a mammalian tissue source, the acellular ECM exhibiting a flexible, porous, expandable structure, which is adapted to expand upon exposure to and absorption of a bodily fluid, wherein the construct seals a perivalvular leak when disposed proximate thereto.