Valve Insertion Device with Pressure Sensor for Aortic Traversal

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Solution Overview

Problem

The difficulty in traversing stenotic and calcified aortic valves with wire guides during medical procedures, such as valvuloplasty and stenting, due to the valve's anatomy and the need for excessive fluoroscopy, which prolongs procedures and exposes patients to excessive radiation.

Innovation Solution

A valve insertion system that includes a pressure sensor connected to a control system to detect and predict valve openings, automatically actuating a wire guide advancement system to navigate through the valve, reducing the need for manual alignment and fluoroscopy.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a wire guide is manually advanced through the aortic valve using fluoroscopy guidance, then the valve can be traversed, but the procedure time increases and patient radiation exposure increases

Engineering Contradiction:
Improvevalve traversal successVSAvoidprocedure time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The system performs preliminary detection of valve opening timing using pressure sensors before the wire guide advancement attempt. By detecting pressure changes that indicate valve opening, the system prepares the advancement mechanism in advance and executes the traversal during the optimal window, eliminating the need for repeated fluoroscopy-guided attempts and reducing procedure time

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The pressure sensor provides real-time feedback about valve opening events to the control system. This feedback loop allows the system to automatically synchronize wire guide advancement with valve opening, ensuring reliable traversal while minimizing the time the wire guide needs to be manipulated under fluoroscopy

Inventive Principle:
Principle #23Feedback

2Reliability

If fluoroscopy is used to guide wire guide advancement through the aortic valve, then the valve can be traversed, but the patient is exposed to excessive radiation

Engineering Contradiction:
Improvevalve traversal successVSAvoidradiation exposure
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The system replaces fluoroscopy (radiation-based imaging) with a mechanical pressure sensing mechanism to detect valve opening. The pressure sensor detects pressure changes in the aorta that occur when the aortic valve opens, providing a radiation-free method to guide wire guide advancement timing

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

Solution Approach 2:

The pressure sensor and control system automatically detect valve opening events and trigger wire guide advancement without requiring continuous fluoroscopy monitoring. The system uses the body's own pressure changes as a signal, eliminating the need for external radiation-based guidance

Inventive Principle:
Principle #25Self-service

3Strength

If the aortic valve is stenotic and calcified, then the valve structure is more rigid, but it becomes difficult to pass even a wire guide through the valve

Engineering Contradiction:
Improvevalve structural integrityVSAvoidwire guide passage
Core Design Contradiction:
StrengthVSEase of operation

Solution Approach 1:

The system exploits the dynamic opening motion of the calcified valve rather than trying to force the wire guide through a static structure. By detecting the natural opening event through pressure changes and synchronizing advancement with this dynamic phase, the wire guide can pass through the opened valve leaflets more easily

Inventive Principle:
Principle #15Dynamics

4Adaptability or versatility

If the artery leading up to the valve is curved, then the anatomical path is complex, but it becomes difficult to align the wire guide with the valve opening

Engineering Contradiction:
Improveanatomical path navigationVSAvoidvalve opening alignment
Core Design Contradiction:
Adaptability or versatilityVSEase of operation

Solution Approach 1:

The pressure sensor provides feedback about valve opening timing, allowing the operator to advance the wire guide precisely when the valve opens. This temporal feedback compensates for the difficulty of spatial alignment caused by arterial curvature, as the pressure wave travels through the curved artery to reach the sensor

Inventive Principle:
Principle #23Feedback

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

Facilitates easier traversal of aortic valves with wire guides, shortening procedure time and minimizing patient radiation exposure by automating the valve traversal process.

Implementation Method 1

A pressure sensor is placed alongside the wire guide so that it can detect the fluid pressure of the region near the outflow of the valve

Methodology Applied
Scientific EffectPressure detection:

Implementation Method 2

by measuring the time between pressure spikes, the control system can predict when the valve will open

Methodology Applied
Scientific EffectTime measurement:

Data Source

PatentUS9539090B2Transaortic valve access device
Publication Date: 2017.01.10 COOK MEDICAL TECHNOLOGIES LLC
  • US9539090B2 patent drawing
  • US9539090B2 patent drawing
  • US9539090B2 patent drawing

AI summary

A valve insertion device for traversing a wire guide through a valve within an intraluminal passage. A wire guide is positioned near the outflow of a valve within an intraluminal passage. Alongside the wire guide, a pressure sensor is positioned to detect the pressure of the fluid in the intraluminal passage. As the valve opens, the fluid pressure at the outflow of the valve increases. This information is sent from the pressure sensor to a control system. From this information, the control system can determine when the valve will open and can actuate an advancement system to move the wire guide to traverse the open valve. After traversing the valve, various catheters and sheaths may be advanced over the wire guide through the valve.