Expandable Heart Valve Frame with Peaked Wire Structure

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Solution Overview

Problem

Existing heart valve implant apparatuses face challenges with sheath strength, flexibility, and manufacturing costs, particularly in expanding to accommodate larger devices during procedures, which can lead to vascular trauma and increased procedure time.

Innovation Solution

A transcatheter heart valve implant apparatus featuring a radially expandable frame with a wire structure comprising peak and valley portions made from materials like nickel titanium or stainless steel, allowing for selective expansion and contraction to accommodate varying device sizes, and a cover and jacket for enhanced strength and flexibility.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If a traditional sheath is used, then the structure is simple, but the strength and flexibility are insufficient

Engineering Contradiction:
Improvesheath strengthVSAvoidframe structure complexity
Core Design Contradiction:
StrengthVSDevice complexity

Solution Approach 1:

The frame is divided into multiple wire components (first wire, second wire, third wire) with different configurations. The first wire has peak portions and valley portions that provide radial strength, while the second and third wires provide axial flexibility. This segmentation allows each component to specialize in specific mechanical properties, resolving the contradiction between strength and complexity.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The frame uses a composite structure combining multiple wire materials with different characteristics. The first wire (peaked configuration) provides radial strength, while the second and third wires (different configurations) provide flexibility. This composite approach allows the frame to simultaneously achieve both strength and flexibility without requiring a completely new material invention.

Inventive Principle:
Principle #40Composite materials

2Productivity

If a traditional sheath is used, then the manufacturing process is simple, but the manufacturing cost and time are high

Engineering Contradiction:
Improvemanufacturing efficiencyVSAvoidmanufacturing complexity
Core Design Contradiction:
ProductivityVSEase of manufacture

Solution Approach 1:

The frame is segmented into multiple independently manufacturable wire components that can be produced separately using standard wire forming processes. Each wire can be manufactured, shaped, and quality-checked independently before assembly, which improves manufacturing efficiency and reduces overall production time while maintaining ease of manufacture through modular construction.

Inventive Principle:
Principle #1Segmentation

3Adaptability or versatility

If a fixed-size sheath is used, then the structure is simple, but it cannot accommodate varying device sizes

Engineering Contradiction:
Improvedevice size accommodationVSAvoidexpandable structure complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The frame transitions from a static, fixed-size structure to a dynamic, expandable structure. The wire configuration with peak portions and valley portions allows the frame to change its radial diameter while maintaining structural integrity. This dynamic capability enables the sheath to accommodate varying device sizes without requiring multiple fixed-size sheaths, resolving the contradiction between adaptability and complexity.

Inventive Principle:
Principle #15Dynamics

4Adaptability or versatility

If the sheath expands to accommodate larger devices, then device compatibility improves, but vascular trauma increases

Engineering Contradiction:
Improvedevice compatibilityVSAvoidvascular trauma
Core Design Contradiction:
Adaptability or versatilityVSObject-affected harmful factors

Solution Approach 1:

The frame's dynamic expansion capability allows it to adapt to different device sizes through controlled radial expansion. The wire configuration with peak and valley portions enables gradual, controlled expansion that reduces abrupt changes in diameter, thereby minimizing vascular trauma while maintaining device compatibility across various sizes.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The frame utilizes parameter changes in wire configuration (peak portions, valley portions, wire diameters) to control expansion characteristics. By adjusting these geometric parameters, the frame can achieve gradual, controlled expansion that accommodates larger devices while minimizing harmful mechanical stress on the vasculature, thus reducing vascular trauma.

Inventive Principle:
Principle #35Parameter changes

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

The apparatus reduces vascular trauma, procedure time, and complications by enabling selective expansion and contraction, maintaining radial strength and flexibility, and accommodating devices of various sizes without the need for multiple sheath sizes.

Implementation Method 1

a frame extending along a frame axis and radially expandable between a first position, in which the frame comprises a first cross-sectional size, and a second position, in which the frame comprises a second cross-sectional size different than the first cross-sectional size

Methodology Applied
Scientific EffectElasticity: Elasticity

Implementation Method 2

The wire comprises one or more of nickel titanium or stainless steel

Methodology Applied
Scientific EffectShape memory alloy: Shape Memory Alloy

Data Source

PatentUS20240245508A1Heart valve implant apparatus
Publication Date: 2024.07.25 MEDTRONIC INC
  • US20240245508A1 patent drawing
  • US20240245508A1 patent drawing
  • US20240245508A1 patent drawing

AI summary

A transcatheter heart valve implant apparatus includes a frame extending along a frame axis and radially expandable between a first position and a second position. The frame includes a wire extending circumferentially around the frame axis to define a lumen. The wire includes a first peak portion including a first amplitude measured from a plane perpendicular to the frame axis, a second peak portion including a second amplitude measured from the plane, and a valley portion attaching the first peak portion and the second peak portion. The first amplitude is different than the second amplitude, and the first peak portion and the second peak portion are positioned on a first side of the plane and the valley portion is positioned on an opposing second side of the plane. A cover extends along the frame axis and covers an outer radial side of the wire opposite the lumen.