Heart Valve Leaflet Capture Device for Minimally Invasive Coaptation

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Solution Overview

Problem

Current methods for treating valvular regurgitation, such as implanting prosthetic valves or surgically modifying native heart valves, are often invasive, complex, and require lengthy recovery periods, leaving a need for minimally invasive devices and methods to improve coaptation of heart valve leaflets.

Innovation Solution

A leaflet capture device with clip portions that can be deployed separately onto heart valve leaflets, secured with a tether and locking mechanism, to bring leaflets into closer proximity and improve coaptation, reducing regurgitation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If surgical repair or replacement of heart valves is performed, then valvular regurgitation is treated effectively, but the procedure becomes highly invasive with many complications and lengthy recovery periods

Engineering Contradiction:
Improveeffectiveness of valvular regurgitation treatmentVSAvoidinvasiveness and complexity of surgical procedure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The device is divided into multiple separate clip portions that can be deployed independently onto different leaflets. Each clip portion can be delivered through its own catheter, allowing staged deployment and reducing the complexity of a single complex surgical procedure. The segmented design enables minimally invasive delivery while maintaining the ability to treat multiple leaflets comprehensively

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The clip portions are designed to be deliverable through catheters in a nested configuration, where the clip components are compressed or folded within the delivery catheter lumen. Once positioned, the clips self-expand or are deployed from the catheter, eliminating the need for open surgical exposure while achieving the same therapeutic effect

Inventive Principle:
Principle #7Nested doll (Nesting)

2Reliability

If multiple heart valve leaflets are treated simultaneously, then comprehensive coaptation improvement is achieved, but the procedure complexity and time required increase significantly

Engineering Contradiction:
Improvecomprehensiveness of coaptation improvementVSAvoidprocedure time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

Multiple clip portions are pre-loaded into delivery catheters before the procedure begins. The catheters are advanced to the heart in a single procedure, and the clips are deployed in a predetermined sequence. This preliminary preparation eliminates the need for multiple separate surgical interventions and reduces overall procedure time while ensuring comprehensive treatment of all affected leaflets

Inventive Principle:
Principle #10Preliminary action

3Ease of operation

If clip portions are deployed separately onto leaflets, then minimally invasive delivery is achieved, but the difficulty of positioning and securing multiple separate clips increases

Engineering Contradiction:
Improveminimally invasive delivery capabilityVSAvoiddifficulty of positioning and securing clips
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

A tether connects the separate clip portions, serving as an intermediary element that links them together. The tether allows the clips to be positioned independently on different leaflets while maintaining a mechanical connection that facilitates simultaneous securing. This intermediate connection simplifies the deployment process by providing a unified control mechanism for multiple separate clips

Inventive Principle:
Principle #24Intermediary (Mediator)

Data Source

PatentUS20240252318A1Heart valve coaptation device
Publication Date: 2024.08.01 EDWARDS LIFESCIENCES CORP
  • US20240252318A1 patent drawing
  • US20240252318A1 patent drawing
  • US20240252318A1 patent drawing

AI summary

A device for repairing a heart valve includes a first clip and a second clip. The first clip comprises an inner portion and an outer portion. The inner and outer portions of the first clip are configured to compress tissue of a first heart valve leaflet therebetween to secure the first clip to the first leaflet. The second clip comprises an inner portion and an outer portion. The inner and outer portions of the second clip are configured to compress tissue of a second heart valve leaflet therebetween to secure the second clip to the second leaflet. The first and second clips are configured to be separately deployable onto the first and second leaflets and secured to one another in vivo to bring portions of the first and second leaflets into closer proximity to each other.