Pressure Measuring Catheter with Adenosine Infusion Controller

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Solution Overview

Problem

Conventional Fractional Flow Reserve (FFR) calculations in blood vessels are hindered by the need for multiple guide wire insertions and the adverse effects of adenosine, a pharmacological hyperemic agent used to stabilize vascular resistance, which causes patient discomfort and requires minimization.

Innovation Solution

A pressure measurement catheter with separate lumens for a guide wire, fluid, and pressure sensing, where adenosine is administered through the fluid lumen to stabilize pressure measurements, with a controller managing adenosine injections to maintain minimal resistance for accurate FFR calculations.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If adenosine is administered to reduce vascular resistance for accurate FFR measurements, then measurement precision is improved, but patient discomfort increases due to side effects

Engineering Contradiction:
ImproveFFR measurement accuracyVSAvoidpatient discomfort
Core Design Contradiction:
Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The system administers adenosine in controlled partial doses rather than continuous full dosage. The controller monitors pressure measurements and stops adenosine administration once the target pressure (indicating minimal vascular resistance) is achieved, preventing excessive adenosine exposure and reducing side effects while maintaining measurement accuracy

Inventive Principle:
Principle #16Partial or excessive action

Solution Approach 2:

The system uses real-time pressure feedback from the distal pressure sensor to control adenosine administration. The controller continuously monitors Pd (distal pressure) and adjusts or stops adenosine infusion when the pressure stabilizes at the target level, ensuring accurate FFR measurements while minimizing patient exposure to adenosine side effects

Inventive Principle:
Principle #23Feedback

2Ease of operation

If conventional guide wires are used instead of FFR guide wires, then ease of operation is improved, but device complexity increases due to multiple wire insertions

Engineering Contradiction:
Improveguide wire usageVSAvoidmultiple wire insertions
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The system combines multiple functions into a single integrated catheter: pressure measurement capability, adenosine administration lumen, and guidewire support. This allows the use of a conventional guidewire through the catheter while simultaneously performing FFR measurements and controlled adenosine delivery, eliminating the need for separate FFR-specific guidewires and reducing procedural steps

Inventive Principle:
Principle #5Merging (Combining)

3Measurement precision

If multiple guide wire insertions are performed to achieve FFR measurements, then measurement precision is maintained, but loss of time increases due to insertion and retraction steps

Engineering Contradiction:
ImproveFFR measurement accuracyVSAvoidprocedural time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The catheter integrates pressure sensing, adenosine delivery, and guidewire support functions into a single device. This allows the operator to use a conventional guidewire already in place while simultaneously obtaining accurate FFR measurements through the integrated pressure sensor, eliminating the time-consuming process of removing and reinserting specialized FFR guidewires

Inventive Principle:
Principle #5Merging (Combining)

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 accurate FFR calculations with reduced vascular resistance and minimized adenosine administration, reducing patient discomfort and improving clinical efficiency by allowing the use of conventional guide wires instead of FFR guide wires.

Implementation Method 1

The pressure sensing wire lumen may extend to the distal portion of the elongate shaft to be coupled to a pressure sensor disposed at the distal tip for measuring a pressure of a fluid within lumen of vessel that is distal to a lesion or Pd

Methodology Applied
Scientific EffectPressure sensing:

Implementation Method 2

Currently, pharmacological hyperemic agents, such as adenosine, are administered to reduce and stabilize the resistance within the coronary arteries. These vasodilator agents reduce the dramatic fluctuation in resistance to obtain a relatively stable and minimal resistance value

Methodology Applied
Scientific EffectVasodilation:

Data Source

PatentEP3518752A1Pressure measuring catheter with adenosine infusion
Publication Date: 2019.08.07 MEDTRONIC VASCULAR INC

AI summary

An intracoronary catheter measures pressure distal to a lesion (Pd) and has a fluid lumen for administers adenosine to a patient's vasculature. A controller is configured to provide an injection of adenosine, wait for a period of time, measure Pd, and compare Pd to the Pd measured before the injection of the adenosine. If the difference between the pressures is small or below a threshold, the controller will stop further injections of adenosine because Pd has been determined to be at a relatively constant value. If the pressure difference is large or above a threshold, the controller will provide another adenosine injection, wait for a time period and again measure Pd and compare it to the previous Pd. This process will continue until the measured Pd reaches a relatively constant value.