Coronary Diagnostic Assembly with Wire Guide for Cardiac Pacing
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Solution Overview
Problem
Current methods for measuring fractional flow reserve (FFR) in coronary arteries are delicate and often cause undesirable side effects due to the administration of hyperemia-inducing drugs like adenosine, which can lead to heart rate disorders and other complications.
Innovation Solution
A coronary diagnostic set that includes an accessory catheter with a conductive sleeve for electrical connection to an external cardiac stimulator, and a guide-filter with a pressure sensor for FFR measurement, allowing for simultaneous cardiac stimulation during FFR measurement to avoid the need for adenosine.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If adenosine is administered to induce hyperemia for FFR measurement, then FFR measurement can be performed, but heart rate disorders and other side effects occur
Solution Approach 1:
The patent removes adenosine from the FFR measurement process by introducing an external pacemaker to provide cardiac stimulation instead. The pacemaker delivers electrical stimulation through electrodes positioned in the right atrium and right ventricle, eliminating the need for pharmacological hyperemia induction and avoiding associated side effects.
Solution Approach 2:
The external pacemaker acts as an intermediary device between the operator and the coronary artery system. Instead of using adenosine to indirectly induce hyperemia, the pacemaker directly controls cardiac rhythm and rate, providing a safer mediating mechanism to achieve the desired physiological state for FFR measurement.
2Measurement precision
If adenosine is used for FFR measurement, then coronary flow reserve can be assessed, but cardiac pauses and vagal malaise may occur
Solution Approach 1:
The patent extracts adenosine from the measurement protocol and replaces it with pacemaker-mediated cardiac stimulation. This eliminates the generation of harmful factors such as cardiac pauses and vagal malaise while preserving the ability to assess coronary flow reserve through FFR measurement.
Solution Approach 2:
The patent converts the potential harm of uncontrolled cardiac responses during hyperemia into a benefit by using the pacemaker to deliberately control cardiac rhythm. The pacemaker's ability to regulate heart rate and prevent arrhythmias transforms a potential safety issue into a protective mechanism during FFR measurement.
3Reliability
If adenosine administration is performed, then FFR can be measured, but transient cardiac arrest may occur
Solution Approach 1:
The patent removes adenosine from the FFR measurement process and replaces it with controlled electrical stimulation via an external pacemaker. This extraction eliminates the risk of transient cardiac arrest associated with adenosine while maintaining the ability to perform reliable FFR measurements through pacemaker-mediated cardiac control.
Solution Approach 2:
The external pacemaker provides beforehand cushioning by being pre-positioned and programmed to deliver appropriate cardiac stimulation during the FFR measurement procedure. This protective measure is in place before any potential adverse events can occur, preventing transient cardiac arrest through proactive rhythm control.
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
This solution secures the FFR measurement procedure by eliminating side effects associated with adenosine use, enabling FFR measurement in any patient, including those with contraindications to adenosine, and allowing for coronary angioplasty with stent installation.
Implementation Method 1
a pressure sensor for measuring coronary reserve
Implementation Method 2
the sleeve being made of electrically conductive material on at least part of its outer periphery... connected to an electrode of a pacemaker external to the body... a metal part also serving as a connection to the other electrode of the external cardiac pacemaker
Data Source
Figure 1
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AI summary
The invention essentially consists of a coronary diagnostic assembly, the wire guide of which serves both to measure transstenotic pressures for a fractional flow reserve (FFR), by means of the pressure sensor integrated into the wire guide, and to perform cardiac pacing during said FFR measurement.