Inversion Delivery Mechanism for Repositionable Prosthetic Valves

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Solution Overview

Problem

Existing percutaneous valve replacement methods face challenges such as leakage around the prosthetic valve, emboli formation, non-conformity to native lumens, inflexibility, non-adjustability, and inability to retrieve or reposition stents, leading to complications and inefficiencies in valve replacement surgeries.

Innovation Solution

A delivery device that attaches to a braided implant at the aortic flare, providing precise positioning and inversion, with attachment mechanisms that stabilize the implant during deployment and allow for verification of function before release, and includes a limiter to prevent excessive advancement.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a stent is used to support the prosthetic valve, then the valve can be delivered percutaneously, but leakage around the valve increases due to non-conformity to native lumens

Engineering Contradiction:
Improvepercutaneous delivery capabilityVSAvoidsealing performance
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent employs a flexible stent structure with radially expandable elements that can conform to the native lumen geometry. The stent includes a flexible body with multiple struts that can adapt to irregular surfaces, improving sealing while maintaining percutaneous deliverability through compressed delivery configuration.

Inventive Principle:
Principle #30Flexible shells and thin films

Solution Approach 2:

The stent design allows for parameter changes in radial dimension during deployment. The stent transitions from a compressed low-radial-dimension state during delivery to an expanded high-radial-dimension state at the implantation site, enabling both percutaneous delivery and effective sealing.

Inventive Principle:
Principle #35Parameter changes

2Productivity

If a stent is deployed to replace the valve, then valve replacement is achieved, but the stent cannot be retrieved or repositioned

Engineering Contradiction:
Improvevalve replacement efficiencyVSAvoidretrievability
Core Design Contradiction:
ProductivityVSEase of repair

Solution Approach 1:

The stent is designed with dynamic characteristics allowing it to transition between compressed and expanded states. The stent can be compressed back into the delivery catheter for retrieval or repositioning, providing operational flexibility while maintaining deployment efficiency when needed.

Inventive Principle:
Principle #15Dynamics

3Reliability

If the stent is expanded against the valve cusps, then the prosthetic valve is secured, but emboli formation increases

Engineering Contradiction:
Improvevalve securationVSAvoidemboli formation
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The stent features localized engagement points with the valve cusps rather than uniform expansion. Specific struts or engagement elements are positioned to secure the valve at critical locations while minimizing overall tissue disruption and emboli generation during deployment.

Inventive Principle:
Principle #3Local quality

4Stability of the object's composition

If the stent structure is made stronger to maintain position, then positioning stability improves, but flexibility decreases

Engineering Contradiction:
Improvepositioning stabilityVSAvoidflexibility
Core Design Contradiction:
Stability of the object's compositionVSAdaptability or versatility

Solution Approach 1:

The stent utilizes composite construction combining materials with different mechanical properties. The stent body incorporates both rigid elements for positioning stability and flexible elements for adaptability, achieving a balance between maintaining position and conforming to native anatomy.

Inventive Principle:
Principle #40Composite materials

Data Source

PatentUS12502276B2Inversion delivery device and method for a prosthesis
Publication Date: 2025.12.23 EDWARDS LIFESCIENCES CORP
  • US12502276B2 patent drawing
  • US12502276B2 patent drawing
  • US12502276B2 patent drawing

AI summary

A delivery device usable to deliver an inverting implant is provided that includes a positioning mechanism that automatically initiates the inversion process once a predetermined length of the implant has exited a delivery catheter. The positioning mechanism allows the implant to be safely and accurately deployed with reduced operator experience and in a greater variety of target locations.