Stent Deployment Device With Temporary Valve For Blood Flow

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Solution Overview

Problem

Current stent deployment methods, particularly for heart valves, face challenges with blood flow occlusion during expansion, requiring complex pacing and balloon inflation techniques, which are not suitable for all patients, especially in developing regions lacking advanced surgical facilities.

Innovation Solution

A stent deployment device with elongate wings that expand radially to secure and deploy a stent, featuring a temporary valve for unidirectional blood flow and an annular balloon for additional expansion, along with flexible locator arms for precise positioning, allowing for controlled deployment without occluding blood flow.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If a balloon-based expansion system is used for stent deployment, then the stent can be effectively expanded and positioned, but blood flow is occluded during the expansion process

Engineering Contradiction:
Improvestent expansion precisionVSAvoidblood flow occlusion
Core Design Contradiction:
Manufacturing precisionVSObject-affected harmful factors

Solution Approach 1:

The device divides the expansion function into two separate components: a balloon for radial expansion of the stent and a mechanical linkage for longitudinal deployment. This segmentation allows the balloon to expand the stent without blocking the flow path, as the balloon is positioned concentrically within the stent rather than in the flow path.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

A temporary valve is introduced as an intermediary element in the flow path during deployment. This valve permits blood flow to continue during the deployment process while allowing the stent to be expanded and positioned, thereby mediating between the expansion requirement and the blood flow maintenance requirement.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If rapid right ventricular pacing is performed prior to balloon inflation, then cardiac ejection is significantly reduced and valve dislodgement risk is lowered, but the procedure becomes more complex and time-consuming

Engineering Contradiction:
Improvevalve dislodgement preventionVSAvoidpacing and inflation complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The invention extracts the expansion function from the balloon inflation process and implements it through a mechanical linkage system. This removes the need for rapid pacing and complex balloon inflation protocols, as the mechanical system can deploy the stent without requiring transient cardiac suppression.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent replaces the physiological control method (rapid pacing to reduce cardiac ejection) with a mechanical control system. The mechanical linkage directly displaces the stent to the desired position without requiring manipulation of cardiac rhythm, thereby simplifying the procedure while maintaining reliability.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

3Object-affected harmful factors

If a mechanical dilatation mechanism is used instead of a balloon, then blood flow is not occluded during expansion, but the device is not suitable for use with heart valve replacements

Engineering Contradiction:
Improveblood flow occlusionVSAvoidsuitability for heart valve replacements
Core Design Contradiction:
Object-affected harmful factorsVSAdaptability or versatility

Solution Approach 1:

The device combines multiple functions in a single system: the mechanical linkage provides both the expansion mechanism (avoiding flow occlusion) and the deployment mechanism for heart valve replacements. The temporary valve component specifically enables compatibility with valve replacements by allowing unidirectional flow during deployment, making the device universally applicable to both stent expansion and valve replacement procedures.

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

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

Enables safe and precise deployment of stents without occluding blood flow, reducing the need for complex pacing and advanced imaging, making off-pump heart valve replacements possible, especially in resource-limited settings, and improving stent placement accuracy.

Implementation Method 1

a temporary valve is provided in such flow path to permit flow of blood though the flow path predominantly in one direction

Methodology Applied
Scientific EffectValve mechanism: Valve

Implementation Method 2

an annular expansion balloon to be provided over the wings the expansion balloon being inflatable to expand circumferentially to cause a second phase of expansion of a stent carried on the device

Methodology Applied
Scientific EffectBalloon inflation: Pressure Increase

Implementation Method 3

the wings being movable between a radially withdrawn delivery position and expanded positions in which they are displaced radially outwards of the body

Methodology Applied
Scientific EffectRadial expansion: Mechanical Force

Data Source

PatentEP2344090B8A stent deployment device
Publication Date: 2017.11.08 XSAT PTY LTD

AI summary

A stent deployment device (1 ) over which a stent (2) is securable for the purpose of delivery into an operative position in a human body is provided. The device comprises a plurality of elongate wings (16), each of which has a length consistent with the length of a stent to be deployed using the deployment device, the wings being arranged circumferentially about a central body (10) which extends from, and is operable through, a catheter (14). The wings are movable between a radially withdrawn delivery position and expanded positions in which they are displaced radially outwards of the body. A flow path (105) is defined internally of the wings in the expanded positions thereof and a temporary valve (68) is provided in such flow path to permit the flow of blood though the flow path predominantly in one direction. An inflatable annular balloon (80) is preferably provided over the wings to cause final expansion of the stent. Locator arms (40) are deployable from the body to assist in locating the body within a natural heart valve (101 ).