Implantable Valve Device With Segmented Base Body

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Solution Overview

Problem

Existing implantable devices for replacing organ valves face challenges such as poor anchoring in the body, risk of damaging individual elements during deformation, and difficulty in positioning due to complex constructions and the need for balloon catheters, leading to potential blood flow obstruction and instability.

Innovation Solution

An implantable device with a base body formed from a single wire-like element or interconnected wire-like elements through interlocking winding and/or twisting, allowing reversible conversion between primary and secondary shapes for flexible deployment and anchoring, featuring areas of different rigidity and radiopaque markers for precise positioning.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If the anchoring element is made very long to improve anchoring stability, then anchoring reliability is improved, but the risk of blocking blood flow in coronary artery branches increases

Engineering Contradiction:
Improveanchoring stabilityVSAvoidblood flow obstruction
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The base body is divided into multiple sections with different rigidity characteristics. The first and second sections have higher rigidity for anchoring, while the third section has lower rigidity to conform to vessel walls and avoid blocking coronary branches. This segmentation allows different parts to fulfill different functions simultaneously.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Different sections of the base body are designed with locally optimized properties: the first and second sections have higher rigidity for stable anchoring in the aorta, while the third section has lower rigidity to adapt to the vessel wall contour and avoid obstructing coronary artery openings. This local differentiation resolves the contradiction between anchoring stability and blood flow protection.

Inventive Principle:
Principle #3Local quality

2Ease of operation

If the base body is made highly flexible to improve deformability during insertion, then ease of deployment is improved, but the risk of damaging individual elements during deformation increases

Engineering Contradiction:
Improvedeformability during insertionVSAvoidelement integrity
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The base body is constructed as a continuous, seamless structure without sharp corners or rigid joints, resembling a flexible shell that can deform uniformly during insertion and deployment. This design allows high flexibility while distributing mechanical stresses evenly, preventing element damage.

Inventive Principle:
Principle #30Flexible shells and thin films

3Reliability

If the device uses a complex construction with multiple components to improve anchoring and positioning, then anchoring reliability is improved, but the device complexity increases

Engineering Contradiction:
Improveanchoring reliabilityVSAvoidconstruction complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

Multiple functions (anchoring, positioning, flexibility, and structural support) are merged into a single integrated base body structure. The base body itself incorporates varying rigidity sections that provide both anchoring stability and adaptive positioning, eliminating the need for separate anchoring components and simplifying the overall device construction.

Inventive Principle:
Principle #5Merging (Combining)

4Measurement precision

If the device requires balloon catheter expansion for deployment to improve positioning precision, then positioning accuracy is improved, but the device complexity and procedural difficulty increase

Engineering Contradiction:
Improvepositioning accuracyVSAvoiddeployment complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The base body dynamically transitions from a compressed delivery configuration to an expanded functional configuration through self-expansion or simple mechanical actuation. This dynamic transformation enables precise positioning without requiring complex balloon catheter systems, as the device adapts its shape and size in response to the implantation environment.

Inventive Principle:
Principle #15Dynamics

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 device achieves high flexibility and secure fit at the implantation site without risking element damage, allows for precise positioning, and reduces the risk of blood flow obstruction, enhancing stability and ease of deployment.

Implementation Method 1

the basic body can be reversibly transformed from the secondary form into the primary form by applying a force against elastic material forces

Methodology Applied
Scientific EffectElasticity: Elasticity

Implementation Method 2

the membrane element is configured to allow the fluid connection through the base body in a first flow direction and to block it in a second flow direction (opposite to the first flow direction)

Methodology Applied
Scientific EffectValve mechanism: Valve

Data Source

PatentEP2884946B1Implantable device for use in the human and/or animal body to replace an organ valve
Publication Date: 2019.01.02 PFM MEDICAL AG
  • EP2884946B1 patent drawingFigure 1~2
  • EP2884946B1 patent drawingFigure 3a~3d
  • EP2884946B1 patent drawingFigure 4~5

AI summary

The invention relates to an implantable device (1) for use in the human and/or animal body (24) to replace an organ valve, comprising a main body (2) having a first end (3) and a second end (4), wherein the first end (3) and the second end (4) each have an opening to provide a fluid connection through the main body (2) between the first end (3) and the second end (4); and a first membrane element (6) arranged inside or at one end (3, 4) of the main body (2), wherein the membrane element (6) is formed in such a manner that it allows the fluid connection through the main body (2) in a first flow direction and blocks same in a second flow direction opposite the first flow direction; wherein the main body (2) has a large ratio of length to transverse expansion along the longitudinal axis of the main body (2) in a first operating state (primary form) and a smaller ratio of length to transverse expansion along the longitudinal axis of the main body (2) in a second operating state (secondary form); and wherein the main body (2) can be reversibly transferred from the secondary form to the primary form counter to elastic material forces by the application of a force; wherein the main body (2) is formed from a single wire-like element (9) or from a plurality of wire-like elements (9) connected to each other by means of interlocking winding and/or twisting and/or weaving in the manner of a woven and/or layered fabric and/or net.