Interwoven Heart Valve Frame with Integral Hinges

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Solution Overview

Problem

Current frame assembly designs for implantable prosthetic devices, such as prosthetic heart valves, require complex manufacturing processes involving many small parts, which complicates assembly and increases costs. Additionally, these designs often struggle with minimizing the number of individual parts, maintaining flexibility, collapsing to a low profile for minimally invasive introduction, and reducing the risk of rivet embolization.

Innovation Solution

The proposed solution involves an implantable medical device with a radially expandable and compressible annular frame formed by interweaving a first set of inner struts with a second set of outer struts in a plain weave pattern. Each strut is pivotally connected, allowing the frame to be radially compressed and expanded. The method of assembly includes using strut connectors with projections that extend through apertures in the struts to form pivot joints, reducing the number of parts and simplifying the assembly process.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Device complexity

If current frame assembly designs are used, then the structural strength is maintained, but the number of individual parts increases and assembly complexity increases

Engineering Contradiction:
Improvenumber of individual partsVSAvoidstructural strength
Core Design Contradiction:
Device complexityVSStrength

Solution Approach 1:

The patent integrates multiple frame components into a unified structure where the delivery catheter and frame assembly become a single integrated device. The frame is designed as a cohesive unit with interconnected struts and joints that function together, eliminating the need for separate assembly of multiple independent parts during implantation.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The frame design incorporates multi-functional elements where single components serve multiple purposes. The struts provide both structural support and mechanical linkage, the joints enable both articulation and force transmission, and the overall assembly serves both delivery and deployment functions, reducing the total number of specialized parts needed.

Inventive Principle:
Principle #6Universality (Multi-functionality)

2Adaptability or versatility

If the frame is designed with multiple small parts, then the structural flexibility is improved, but the manufacturing process complexity increases

Engineering Contradiction:
Improveflexibility for movement within the patientVSAvoidmanufacturing process complexity
Core Design Contradiction:
Adaptability or versatilityVSEase of manufacture

Solution Approach 1:

The frame is divided into modular segments connected by articulated joints, allowing independent movement and flexibility within each segment while maintaining overall structural integrity. This segmentation enables the frame to adapt to anatomical variations and provide controlled movement during implantation without requiring complex manufacturing of monolithic structures.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The frame incorporates dynamic joints and articulated connections that allow controlled movement and adaptation during implantation. These dynamic elements enable the structure to transition between different configurations (compressed for delivery, expanded for function) while being manufactured as integrated components rather than assembled from multiple rigid parts.

Inventive Principle:
Principle #15Dynamics

3Volume of moving object

If the frame is designed to collapse to low profile, then the minimally invasive introduction is enabled, but the structural stability during operation may be compromised

Engineering Contradiction:
Improveprofile size for catheter introductionVSAvoidstructural stability during operation
Core Design Contradiction:
Volume of moving objectVSStability of the object's composition

Solution Approach 1:

The frame is designed to collapse into a compact, nested configuration for delivery through catheters, with struts and components folding or compressing into a low-profile state. Upon deployment, the frame expands outward to achieve its full functional dimensions and structural stability, transitioning from a compressed delivery state to an expanded operational state.

Inventive Principle:
Principle #7Nested doll (Nesting)

Solution Approach 2:

The frame utilizes materials and structural designs that allow dramatic changes in physical parameters between delivery and operational states. The structure transitions from a compressed, low-volume configuration during catheter introduction to an expanded, high-stability configuration during operation, with the ability to maintain both states as needed for different phases of implantation.

Inventive Principle:
Principle #35Parameter changes

4Reliability

If traditional assembly methods with many parts are used, then the structural integrity is maintained, but the risk of rivet embolization increases

Engineering Contradiction:
Improvestructural integrityVSAvoidrisk of rivet embolization
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The design eliminates rivets and separate fastening components from the frame assembly, removing the source of potential embolization risk. The frame components are integrated through continuous structures, welded joints, or interference-fit connections that do not require removable fasteners, thereby extracting the harmful element (rivets) from the system while maintaining structural integrity through alternative connection methods.

Inventive Principle:
Principle #2Taking out (Extraction)

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

This design minimizes the number of individual parts, enhances flexibility, allows for a low-profile collapse for minimally invasive procedures, and reduces the risk of rivet embolization, thereby improving the manufacturing efficiency and safety of implantable prosthetic devices.

Implementation Method 1

Each first strut is pivotally connected to at least one second strut

Methodology Applied
Scientific EffectHinge: Hinge

Data Source

PatentEP3634316B1Mechanically expandable heart valve
Publication Date: 2025.01.22 EDWARDS LIFESCIENCES CORP
  • EP3634316B1 patent drawingFigure 1
  • EP3634316B1 patent drawingFigure 2
  • EP3634316B1 patent drawingFigure 3A~5

AI summary

In one embodiment, a prosthetic valve can comprise a radially expandable and compressible frame, which can include a plurality of struts which are pivotally joined together without requiring individual rivets. In some embodiments, the struts are interwoven, and can be joined using integral hinges formed in the struts, such as by performing alternate cuts on the struts, bending the struts to form stopper tabs adjacent to joints and/or drilling holes in the struts to facilitate interconnecting struts at joints, or otherwise forming integral hinges and corresponding holes at junction points between the struts. In another embodiment, the frame comprises a plurality of inner struts and outer struts which are connected by a plurality of chains of interconnected rivets, avoiding the need to provide individual rivets at each junction between struts. In still another embodiment, separate hinges are provided to interconnect the struts. In still another embodiment, separate flanged rivets are provided to connect the struts.