Inflatable Mitral Valve Implant for Minimally Invasive Repair

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Solution Overview

Problem

Current methods for correcting mitral regurgitation, a condition where the mitral valve fails to close properly, often require invasive open-heart surgery, which is risky and not suitable for all patients due to its severity and complexity.

Innovation Solution

A heart valve implant system that includes an inflatable valve body, a shaft, and an anchor assembly, allowing for trans-apical or trans-femoral delivery and placement within the heart, with an inflation port for expanding the valve body to address mitral regurgitation without the need for open-heart surgery.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If open-heart surgery is performed to correct mitral regurgitation, then the valve can be repaired or replaced, but the procedure becomes highly invasive with increased risk and complexity

Engineering Contradiction:
Improvevalve repair effectivenessVSAvoidsurgical procedure complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent replaces the mechanical open-heart surgical system with a catheter-based delivery system. The valve implant is delivered through a catheter that can be inserted percutaneously, eliminating the need for sternotomy, cardiopulmonary bypass, and direct surgical manipulation of the heart. This substitution of mechanical access methods reduces surgical complexity while maintaining valve repair effectiveness.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The valve implant utilizes a flexible membrane or thin-walled structure that can be compressed into a delivery catheter and then expanded at the target site. This flexible shell approach allows the valve to be delivered in a collapsed state through a percutaneous route and then deployed in its functional form, avoiding the need for open surgical exposure while ensuring proper valve function.

Inventive Principle:
Principle #30Flexible shells and thin films

2Reliability

If open-heart surgery is performed to correct mitral regurgitation, then the valve can be repaired or replaced, but the procedure requires heart-lung machine and general anesthesia

Engineering Contradiction:
Improvevalve repair effectivenessVSAvoidsurgical accessibility
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent replaces the complex mechanical support system (heart-lung machine) and anesthesia requirement with a percutaneous catheter-based system. The valve implant is delivered through a catheter that can be inserted percutaneously, eliminating the need for sternotomy, cardiopulmonary bypass, and direct surgical manipulation of the heart. This substitution makes the procedure accessible to patients who cannot tolerate open-heart surgery.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The catheter serves as an intermediary device that enables valve delivery without requiring direct surgical access to the heart. The catheter is inserted through a peripheral vessel and navigated to the mitral valve position, allowing the valve implant to be delivered and deployed without open surgical exposure, heart-lung machine support, or general anesthesia.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Manufacturing precision

If a traditional surgical approach is used, then precise valve repair can be achieved, but the recovery time and patient risk increase significantly

Engineering Contradiction:
Improvevalve repair precisionVSAvoidrecovery time
Core Design Contradiction:
Manufacturing precisionVSLoss of time

Solution Approach 1:

The valve implant utilizes a flexible membrane or thin-walled structure that can be compressed into a delivery catheter and then expanded at the target site. This flexible shell approach allows the valve to be delivered in a collapsed state through a percutaneous route and then deployed in its functional form, avoiding the need for open surgical exposure while ensuring proper valve function and reducing recovery time.

Inventive Principle:
Principle #30Flexible shells and thin films

Solution Approach 2:

The valve implant is designed as a segmented or modular structure that can be compressed into sections for delivery through the catheter and then reassembled or expanded at the implantation site. This segmentation allows precise positioning and deployment while minimizing surgical trauma and recovery time.

Inventive Principle:
Principle #1Segmentation

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

Enables minimally invasive correction of mitral regurgitation by delivering and inflating a heart valve implant within the heart, reducing blood flow reversal and improving cardiac output without the risks associated with traditional open-heart procedures.

Implementation Method 1

The shaft includes a lumen in fluid communication with the cavity. An inflation (e.g., injection) port can include one or more lumens in fluid communication with the shaft lumen

Methodology Applied
Scientific EffectInflation: Pressure Increase

Data Source

PatentUS9980812B2Mitral valve spacer and system and method for implanting the same
Publication Date: 2018.05.29 CARDIOSOLUTIONS INC
  • US9980812B2 patent drawing
  • US9980812B2 patent drawing
  • US9980812B2 patent drawing

AI summary

A heart valve implant is disclosed herein. The heart valve implant comprises an inflatable valve body, a shaft, an anchor assembly and an inflation (injection) port. Also disclosed herein, are methods of trans-apically and trans-septally delivering a heart valve implant within a heart such that the valve body can be inflated in situ to partially or completely restrict blood flow through a heart valve in a closed position. The inflation (injection) port permits inflation of the valve body with an adjustable amount of an inflation fluid to attain a desired degree of inflation of the valve body when disposed within the heart valve.