Tiltable Prosthetic Valve Delivery Assembly for Annulus Alignment

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Solution Overview

Problem

The challenge of implanting prosthetic valves via catheterization is control and positioning of the distal end of the delivery apparatus and variation in patient anatomy, making some delivery apparatuses unsuitable for specific anatomies.

Innovation Solution

A prosthetic implant delivery assembly with a pivotable and tiltable expandable stent portion coupled to an elongate catheter, allowing for precise alignment and positioning of the prosthetic valve relative to the native annulus, using a retrograde approach, and featuring movable locking elements and expandable arms for controlled deployment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a rigid delivery apparatus is used to maintain structural stability, then the delivery apparatus can maintain its position, but it cannot adapt to anatomical variations and achieve precise positioning

Engineering Contradiction:
Improvepositioning precisionVSAvoidanatomical adaptability
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The delivery apparatus incorporates a tiltable stent portion that can rotate relative to the catheter body, transforming the rigid structure into a dynamic system. This allows the distal end to be tilted at various angles (e.g., 0-45 degrees) to accommodate anatomical variations and achieve precise alignment with the native annulus, resolving the contradiction between maintaining structural stability and adapting to anatomical variations.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The delivery apparatus is divided into distinct segments: a catheter body, a tiltable stent portion, and a valve component. The stent portion can be independently tilted relative to the catheter body, allowing each segment to serve its specific function while collectively providing both stability and adaptability for precise positioning.

Inventive Principle:
Principle #1Segmentation

2Reliability

If the distal end of the delivery apparatus is made fixed for stable positioning, then positioning reliability is improved, but the ability to reposition and recapture is reduced

Engineering Contradiction:
Improvepositioning stabilityVSAvoidrepositioning capability
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The tiltable stent portion enables the distal end to be dynamically repositioned by tilting it to different angles during the procedure. This dynamic capability allows the operator to adjust the positioning to achieve optimal alignment with the native annulus while maintaining stability during the implantation process, thus preserving both positioning reliability and repositioning capability.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The system allows changing the angular parameter of the stent portion relative to the catheter body. By adjusting the tilt angle parameter, the operator can modify the orientation of the distal end to achieve precise positioning and facilitate repositioning or recapture operations as needed.

Inventive Principle:
Principle #35Parameter changes

3Device complexity

If a standardized delivery apparatus is used for all patients, then device complexity is reduced, but it cannot accommodate variation in patient anatomy

Engineering Contradiction:
Improvedevice simplicityVSAvoidanatomical versatility
Core Design Contradiction:
Device complexityVSAdaptability or versatility

Solution Approach 1:

The delivery apparatus incorporates a tiltable stent portion that can be dynamically adjusted during the procedure. This dynamic feature adds minimal complexity while providing significant anatomical versatility, allowing the same standardized device to adapt to various patient anatomies by tilting the stent portion to appropriate angles (e.g., 0-45 degrees) to match the native annulus orientation.

Inventive Principle:
Principle #15Dynamics

Data Source

PatentUS12440331B2Methods for controlled heart valve delivery
Publication Date: 2025.10.14 EDWARDS LIFESCIENCES CORP
  • US12440331B2 patent drawing
  • US12440331B2 patent drawing
  • US12440331B2 patent drawing

AI summary

A prosthetic implant delivery assembly includes a prosthetic implant and a catheter. The prosthetic implant includes a plurality of apices with apertures. Each apex of the plurality of apices is circumferentially-spaced apart relative to an adjacent apex. The catheter includes a plurality of arms and a plurality of locking elements. Each of the arms includes an opening configured to receive a respective apex of the prosthetic implant. Each of the locking elements is configured to extend through the aperture of a respective apex of the prosthetic implant. A length of at least one of the locking elements is different than a length of another locking element such that when the prosthetic implant is coupled to the catheter by the locking elements, a longitudinal axis of the prosthetic implant can be held at a tilted position relative to a longitudinal axis of the catheter.