Implantable Valve Support Structure with Enhanced Stiffness

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Solution Overview

Problem

Conventional self-expanding prosthetic valve support structures often have insufficient transverse deformation resistance, leading to either inadequate performance in reshaping the tissue or exerting undesirable chronic radial forces on surrounding tissue.

Innovation Solution

The design incorporates a support structure with distinct regions of varying transverse deformation resistance, featuring a first region with lower resistance and a second region with enhanced radial compressive resistance and flat plate stiffness, achieved through geometric and material properties, allowing for increased compressibility in the longitudinal direction and stability in the radial direction.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If conventional self-expanding nitinol frames are used as support structure, then the device can be deployed into calcified aortic annulus, but the support structure either has insufficient flat plate stiffness to perform effectively or exerts undesirable chronic radial forces on surrounding tissue

Engineering Contradiction:

Improveflat plate stiffnessVSAvoidchronic radial forces on surrounding tissue

Core Design Contradiction:

StrengthVSObject-affected harmful factors

Solution Approach 1:

The support structure is divided into two distinct regions: a first region with lower transverse deformation resistance that allows compressibility, and a second region with enhanced transverse deformation resistance that provides structural stability. This local differentiation enables the device to have both compliance for deployment and stiffness for performance without exerting excessive chronic radial forces on surrounding tissue.

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The tubular body is segmented into functionally distinct regions along its length, with each region having different geometric properties and mechanical characteristics. The first region is designed for compressibility during deployment, while the second region is designed for enhanced flat plate stiffness during operation, resolving the contradiction between deployability and structural performance.

Inventive Principle:

Principle #1Segmentation

2Strength

If the support structure has enhanced transverse deformation resistance, then flat plate stiffness is improved, but the device becomes less compressible in the longitudinal direction

Engineering Contradiction:

Improvetransverse deformation resistanceVSAvoidcompressibility in longitudinal direction

Core Design Contradiction:

StrengthVSAdaptability or versatility

Solution Approach 1:

Different regions of the support structure have different geometric properties: the first region has frame elements with dimensions that provide compressibility, while the second region has frame elements with dimensions that provide enhanced transverse deformation resistance. This local quality differentiation allows the device to be compressed during deployment while maintaining structural stability when deployed.

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The support structure is divided into segments with different mechanical properties along its length. The first region is optimized for longitudinal compressibility to facilitate delivery, while the second region is optimized for transverse deformation resistance to provide structural support, thereby resolving the contradiction between compressibility and stiffness.

Inventive Principle:

Principle #1Segmentation

3Ease of operation

If the support structure has insufficient transverse deformation resistance, then the device is more compliant and easier to deploy, but it cannot effectively reshape the tissue

Engineering Contradiction:

ImprovedeployabilityVSAvoidtissue reshaping effectiveness

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The support structure is divided into two regions with different mechanical properties: the first region provides compliance for easy deployment, while the second region provides enhanced stiffness for effective tissue reshaping. This segmentation allows the device to be both easy to deploy and effective in its function.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

Different regions of the support structure have different geometric properties tailored to their specific functions: the first region has properties that facilitate deployment, while the second region has properties that enable effective tissue reshaping. This local quality differentiation resolves the contradiction between ease of deployment and treatment effectiveness.

Inventive Principle:

Principle #3Local quality

Data Source

PatentUS20230110800A1Support structure for an implantable device with enhanced compressive stiffness region(s)

Publication Date: 2023.04.13 WL GORE & ASSOC INC

AI summary

Various examples address support structures (e.g., prosthetic valve support structures or frames) that incorporate a frame that, upon transitioning to a deployed configuration, include a proximal section has increased stiffness, or resistance to deformation in a transverse plane to a longitudinal axis of a device, including resistance to a change in shape, size, or both. Such an increase in transverse deformation resistance may be measured as an increase in radial compressive resistance or an increase in flat plate stiffness, for example, or both. Such increases in transverse deformation resistance may be realized through a reduction in length of the increased stiffness region of the support structure, such as through longitudinal compression of the region following an initial radial expansion of the region.