Segmented Implantable Valve Frame for Radial Strength and Flexibility

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Solution Overview

Problem

Existing implantable medical devices face challenges in maintaining patency of body vessels while regulating fluid flow and minimizing irritation and thrombosis risk due to dynamic changes in vessel shape and blood flow conditions.

Innovation Solution

Radially-expandable intraluminally implantable prosthetic valves with support frames that can move between expanded and compressed configurations, featuring a design with divergent and convergent portions and transverse connecting members to distribute stress and reduce contact area with the vessel wall, along with flexible leaflets for regulating fluid flow.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If an implantable frame with high radial strength is used, then vessel patency is maintained, but flexibility is reduced and vein damage may occur

Engineering Contradiction:
Improveradial strengthVSAvoidflexibility
Core Design Contradiction:
StrengthVSAdaptability or versatility

Solution Approach 1:

The support frame is divided into multiple struts or bars that are interconnected, allowing each element to contribute to radial strength while the overall structure maintains flexibility through the arrangement and connection of these segmented elements

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The support frame is designed with dynamic characteristics that allow it to adapt to pulsatile blood flow and vessel movement, transitioning between states to maintain both strength and flexibility under varying physiological conditions

Inventive Principle:
Principle #15Dynamics

2Stability of the object's composition

If an implantable frame with large surface area is used, then structural stability is improved, but trauma to the vessel wall increases

Engineering Contradiction:
Improvestructural stabilityVSAvoidvessel wall trauma
Core Design Contradiction:
Stability of the object's compositionVSObject-affected harmful factors

Solution Approach 1:

The support frame features varying strut thicknesses and configurations along its length, with thicker elements providing stability where needed and thinner elements reducing contact area and trauma in other regions

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The support frame incorporates curved or angled struts that follow the natural contour of the vessel, distributing contact pressure more evenly and reducing localized trauma while maintaining structural stability

Inventive Principle:
Principle #14Spheroidality (Curvature)

3Object-affected harmful factors

If an implantable frame with insufficient surface area is used, then vessel wall trauma is minimized, but durability is reduced

Engineering Contradiction:
Improvevessel wall traumaVSAvoiddurability
Core Design Contradiction:
Object-affected harmful factorsVSDuration of action of stationary object

Solution Approach 1:

The support frame utilizes composite material structures or surface treatments that enhance durability and wear resistance without increasing the overall surface area in contact with the vessel wall

Inventive Principle:
Principle #40Composite materials

4Stability of the object's composition

If a support frame is designed to maximize contact with vessel wall, then stability is improved, but blood flow stagnation and thrombosis risk increase

Engineering Contradiction:
ImprovestabilityVSAvoidthrombosis risk
Core Design Contradiction:
Stability of the object's compositionVSObject-generated harmful factors

Solution Approach 1:

The support frame is segmented into discrete struts with gaps between them, creating flow channels that allow blood to pass through and around the structure, preventing stagnation and reducing thrombosis risk while maintaining stability

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The support frame incorporates porous or mesh-like structures that facilitate blood flow through the device, reducing stagnation zones and minimizing thrombogenic potential while preserving structural stability

Inventive Principle:
Principle #31Porous materials

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 solution provides sufficient radial strength to maintain vessel patency, minimizes trauma to the vessel wall, and promotes desirable flow patterns to reduce thrombosis risk, effectively addressing the challenges of dynamic vessel changes and fluid regulation.

Implementation Method 1

The support frames are configured to distribute stress and strain forces caused by dynamic movement of the support frame within a body vessel

Methodology Applied
Scientific EffectStress distribution:

Implementation Method 2

an implantable frame with undesirably high levels of radial strength may lack flexibility and may damage the vein by failing to compress in response to normal fluctuations in the vein diameter

Methodology Applied
Scientific EffectElasticity: Elasticity

Implementation Method 3

These conditions, such as more turbulent flow, increased velocity of flow, larger and/or more numerous vortices, other factors, or a combination of the above, can mitigate the incidence of thrombosis formation near the implantable medical device

Methodology Applied
Scientific EffectTurbulence: Turbulence

Data Source

PatentUS8057532B2Implantable frame and valve design
Publication Date: 2011.11.15 COOK MEDICAL TECHNOLOGIES LLC
  • US8057532B2 patent drawing
  • US8057532B2 patent drawing
  • US8057532B2 patent drawing

AI summary

Implantable prosthetic valves comprising support frames are provided. The support frames may include a plurality of symmetrically arrayed interconnected U-shaped member structures. Preferred support frames are tubular structures enclosing a longitudinal axis and including a plurality of U-shaped member structures facing a distal or a proximal end of the support frame. Each U-shaped member structure may be connected to a single longitudinally adjacent U-shaped member facing in an opposite longitudinal direction, as well as two laterally adjacent U-shaped members.