Distal Cap Insert with Radiopaque Markers for Intravascular Device Positioning

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Solution Overview

Problem

Current imaging techniques used in minimally invasive cardiac valve replacement procedures face challenges in accurately determining the position and orientation of delivery devices within the heart, which is crucial for proper valve installation and patient safety.

Innovation Solution

The development of devices and methods that incorporate radiopaque markers and echogenic features within the distal cap of an intravascular device delivery system, allowing for precise visualization under x-ray, ultrasound, or echocardiography, to facilitate accurate alignment and positioning of the delivery device relative to the mitral annulus.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Loss of information

If imaging techniques are used to guide the procedure, then the ability to visualize anatomy is improved, but the ability to accurately determine position and orientation of the delivery device is insufficient

Engineering Contradiction:
Improvevisualization capabilityVSAvoidposition and orientation determination accuracy
Core Design Contradiction:
Loss of informationVSMeasurement precision

Solution Approach 1:

The patent applies radiopaque markers that appear distinct under x-ray imaging, enabling the delivery device to be visualized and precisely positioned relative to anatomical structures. These markers create high-contrast visual signals that allow accurate determination of device location and orientation during the procedure

Inventive Principle:
Principle #32Color changes

Solution Approach 2:

The patent introduces radiopaque markers as intermediary elements between the delivery device and the imaging system. These markers serve as mediators that translate the physical position of the device into visible information on imaging screens, enabling precise spatial awareness without requiring direct visualization of the device itself

Inventive Principle:
Principle #24Intermediary (Mediator)

2Measurement precision

If radiopaque markers are added to the distal cap, then measurement precision is improved, but device complexity increases

Engineering Contradiction:
Improveposition determination accuracyVSAvoidstructure complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent segments the distal cap into functional components, including the elongate member, rim member, wall member, and radiopaque markers. This segmentation allows each component to be optimized independently, with markers added as separate elements that can be positioned precisely without complicating the overall device design

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent applies radiopaque markers only at specific locations on the distal cap where they provide maximum imaging benefit. This localized application of radiopaque material improves position determination accuracy without requiring the entire device to be complex or heavily modified

Inventive Principle:
Principle #3Local quality

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

These innovative features enable more accurate positioning of the delivery device, reducing the risk of improper valve installation and minimizing potential harm to the patient, while enhancing the effectiveness of minimally invasive cardiac valve replacement procedures.

Implementation Method 1

radiopaque marker allowing for precise visualization under x-ray

Methodology Applied
Scientific EffectX-ray: X-Ray

Implementation Method 2

echogenic features within the distal cap of an intravascular device delivery system, allowing for precise visualization under x-ray, ultrasound, or echocardiography

Methodology Applied
Scientific EffectUltrasound: Ultrasound

Data Source

PatentUS12318288B2Insert for distal end cap
Publication Date: 2025.06.03 EVALVE
  • US12318288B2 patent drawing
  • US12318288B2 patent drawing
  • US12318288B2 patent drawing

AI summary

An intravascular device delivery system has an elongated member, a guidewire receiving member, and a distal cap longitudinally fixed to a guidewire receiving member. The distal cap includes an insert having an elongate member, a rim member radially separated from the elongate member, and a wall member supporting the rim member, the wall member being disposed between the rim member and the elongate member.