Prosthetic Valve Delivery Assembly for Accurate Annulus Positioning

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Solution Overview

Problem

Existing transcatheter aortic valve replacement (TAVR) techniques face challenges in accurately positioning prosthetic valves within the native heart valve annulus, leading to issues such as conduction disturbances, misalignment, dislodgement, and paravalvular leakage.

Innovation Solution

The use of delivery assemblies equipped with positioning and stabilization members, including elongated positioning members, positioning balloons, stabilization filters, positioning struts, and positioning arms, to facilitate precise placement and stabilization of prosthetic valves during implantation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If traditional TAVR delivery methods are used, then the procedure can be performed with simpler devices, but the positioning accuracy of the prosthetic valve deteriorates

Engineering Contradiction:

Improvepositioning accuracyVSAvoiddelivery assembly complexity

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

The delivery assembly is divided into multiple functional components: positioning members (elongated elements) that extend into the annulus to define implantation depth, stabilization members (filters) that prevent dislodgement, and the prosthetic valve itself. This segmentation allows each component to perform its specific function independently, achieving high positioning accuracy without requiring the entire assembly to be overly complex.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The positioning members are deployed before the prosthetic valve to establish the correct implantation depth and orientation. The elongated positioning members extend into the annulus and contact the native valve tissue, pre-defining the implantation site. This preliminary action ensures that when the valve is subsequently deployed, it is already positioned with high accuracy, reducing the need for complex real-time adjustment mechanisms.

Inventive Principle:

Principle #10Preliminary action

2Manufacturing precision

If positioning members are added to improve valve placement accuracy, then positioning precision improves, but device complexity increases

Engineering Contradiction:

Improvevalve placement precisionVSAvoiddelivery apparatus complexity

Core Design Contradiction:

Manufacturing precisionVSDevice complexity

Solution Approach 1:

The positioning members serve multiple functions: they define implantation depth, provide stabilization during deployment, and prevent over-expansion of the valve. The stabilization filters also serve dual purposes by preventing dislodgement and potentially filtering emboli. This multi-functionality reduces the need for separate dedicated components for each function, thereby limiting the increase in overall device complexity while achieving high placement precision.

Inventive Principle:

Principle #6Universality (Multi-functionality)

3Stability of the object's composition

If stabilization members are incorporated to prevent dislodgement, then the stability of valve implantation improves, but the device complexity increases

Engineering Contradiction:

Improveimplantation stabilityVSAvoiddelivery assembly complexity

Core Design Contradiction:

Stability of the object's compositionVSDevice complexity

Solution Approach 1:

The stabilization filters are deployed beforehand to create a stabilizing structure that prevents dislodgement of the prosthetic valve. These filters extend into the annulus and provide a cushioning effect that resists forces that might cause dislodgement. By providing this stabilization in advance, the system ensures implantation stability without requiring complex active control mechanisms during the procedure.

Inventive Principle:

Principle #11Beforehand cushioning (Prior cushioning)

4Measurement precision

If multiple positioning members are used to ensure accurate positioning, then positioning accuracy improves, but the difficulty of operation increases

Engineering Contradiction:

Improvepositioning accuracyVSAvoidprocedure ease

Core Design Contradiction:

Measurement precisionVSEase of operation

Solution Approach 1:

Multiple positioning members are combined into a single integrated delivery assembly that is controlled from a single operator interface. The positioning members are arranged in a coordinated manner (e.g., radially spaced) and are deployed simultaneously or in a predetermined sequence, allowing the operator to control them as a unified system rather than separate components. This merging approach maintains high positioning accuracy while simplifying the operational complexity for the operator.

Inventive Principle:

Principle #5Merging (Combining)

Data Source

PatentUS20260060803A1Prosthetic valves and delivery assemblies with positioning and stabilization members

Publication Date: 2026.03.05 EDWARDS LIFESCIENCES CORP

AI summary

The present disclosure relates to devices designed to aid in accurate positioning and deployment of prosthetic valves inside a native annulus. In an example, a delivery assembly comprises a prosthetic valve comprising a frame movable between radially compressed and expanded configurations, and a delivery apparatus. The delivery apparatus includes an outer delivery shaft, and at least one elongated positioning member extending through, and axially movable relative to, the outer delivery shaft. The elongated positioning member is configured to position a distal end thereof radially outward to the prosthetic valve and axially distal to an outflow end of the frame. In some examples, the delivery apparatus can further include at least one sensor attached to the elongated positioning member.