Bioabsorbable Gasket for Percutaneous Heart Valve Sealing

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Solution Overview

Problem

Percutaneous heart valve implantation methods face challenges with leakage and stroke risk due to mismatch between circular/cylindrical valves and diseased vessels, particularly in the initial weeks and months post-implantation.

Innovation Solution

A percutaneous prosthetic heart valve assembly featuring a radially expandable anchor docking member and a bioabsorbable gasket made of polymer material, which expands to fit the vessel, securely engaging an implantable heart valve and degrading over time to prevent migration and leakage.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a percutaneous valve implantation is performed, then the invasiveness is reduced and recovery is faster, but the risk of leakage and stroke increases due to mismatch between circular valve and diseased vessel

Engineering Contradiction:
ImproveinvasivenessVSAvoidleakage risk
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

A bioabsorbable gasket is deployed ahead of the valve implant to pre-seal the mismatch gap between the circular valve and diseased vessel. The gasket is positioned first, then the valve is implanted over it, creating a preliminary seal that prevents leakage before the valve is fully deployed

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The bioabsorbable gasket serves as an intermediary element between the circular valve and the irregularly shaped diseased vessel. It fills the geometric mismatch and creates a sealing interface, mediating the compatibility between the two components

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If a fixed structural gasket is used to seal the valve-vessel interface, then leakage is prevented, but the device complexity and long-term foreign body burden increase

Engineering Contradiction:
Improvesealing performanceVSAvoiddevice complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The gasket is designed to be temporary rather than permanent. It performs its sealing function during the critical initial period after implantation, then progressively degrades and is absorbed by the body, eliminating the need for long-term retention and reducing foreign body burden

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The gasket material undergoes parameter changes over time, transitioning from an intact sealing structure to a degrading state, and finally to complete absorption. This temporal parameter change allows the gasket to provide sealing when needed and disappear when no longer required

Inventive Principle:
Principle #35Parameter changes

3Stability of the object's composition

If the valve is securely anchored to prevent migration, then positioning stability is improved, but the ability to reposition or remove the valve is reduced

Engineering Contradiction:
Improvepositioning stabilityVSAvoidrepositioning capability
Core Design Contradiction:
Stability of the object's compositionVSEase of repair

Solution Approach 1:

The anchoring system transitions from a dynamic state during implantation (where the valve can be positioned and adjusted) to a stable state after deployment (where the valve is secured against migration). The expandable anchor provides initial securement while maintaining the possibility of controlled manipulation during the deployment process

Inventive Principle:
Principle #15Dynamics

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 solution reduces the risk of leakage and stroke by securely anchoring the prosthetic valve to the vessel, minimizing initial post-implantation risks and allowing for repositioning or removal, while the bioabsorbable gasket ensures long-term stability and integration with the body.

Implementation Method 1

the bioabsorbable gasket member comprising a bioabsorbable polymer material

Methodology Applied
Scientific EffectBiodegradation: Decomposition (biological)

Data Source

PatentUS10172708B2Valve assembly with a bioabsorbable gasket and a replaceable valve implant
Publication Date: 2019.01.08 BOSTON SCIENTIFIC SCIMED INC
  • US10172708B2 patent drawing
  • US10172708B2 patent drawing
  • US10172708B2 patent drawing

AI summary

A percutaneous prosthetic heart valve assembly comprising a radially expandable anchor docking member, the anchor docking member having an unexpanded state and an expanded state, in the expanded state, the anchor docking member comprising a mechanism for receiving and engaging an implantable heart valve and a bioabsorbable gasket member disposed about the anchor docking member, the bioabsorbable gasket member comprising a bioabsorbable polymer material, the bioabsorbable gasket member having an unexpanded and an expanded state.