Optical coherence tomography and pressure based systems and methods

Patent metadata

Field	Value
Publication number	US-12193789-B2
Application number	US-202016937117-A
Country	US
Kind code	B2
Filing date	Jul 23, 2020
Priority date	May 27, 2011
Publication date	Jan 14, 2025
Grant date	Jan 14, 2025

Abstract

In part, the invention relates to methods, apparatus, and systems suitable for determining a fractional flow reserve (FFR) and variations of modifications thereof One embodiment relates to a method and apparatus for obtaining a corrected FFR in a vessel having a stenosis. In one aspect, the invention relates to an apparatus for measuring corrected FFR of a vessel having a stenosis. In one embodiment, the apparatus includes a probe comprising an optical coherence tomography assembly and a pressure assembly; and a processor in communication with the optical coherence tomography assembly and the pressure assembly. In one embodiment, the pressure assembly measures values of pressure in predetermined locations the vessel and communicates them to the processor. In one embodiment, a dual guidewire is used to reduce the interference in the pressure measurement.

First claim

The invention claimed is:

1. A method of determining one or more intravascular parameters of a blood vessel comprising:
receiving, at one or more processors from an intravascular probe, intravascular image data relating to the blood vessel;
determining, based on the intravascular image data, a first geometric boundary of a first portion of a lumen of the vessel;
determining, based on the intravascular image data and the first geometric boundary, a second geometric boundary of a second portion of the lumen of the vessel different from the first portion, the second portion of the lumen being located behind a guidewire disposed within the lumen;
determining, based on the first geometric boundary and the second geometric boundary, a third geometric boundary of the guidewire, the third geometric boundary being located within the first geometric boundary and the second geometric boundary;
measuring, using a pressure measuring device disposed within the intravascular probe, one or more pressure values at one or more predetermined locations in the vessel;
determining, using the one or more processors based on the one or more pressure values, a first fractional flow reserve of the vessel;
iteratively correcting a hyperemic microvascular resistance index until a predefined error limit is reached, wherein the hyperemic microvascular resistance index is determined using a calculated pressure drop value and the one or more pressure values, wherein the predefined error limit relates to the difference between the calculated pressure drop and the difference between the one or more pressure values;
calculating, based on the one or more pressure values and the corrected hyperemic microvascular resistance value, an estimated pressure drop associated with removal of the third geometric boundary from the vessel;
calculating, using the one or more processors based on the estimated pressure drop, a first corrected fractional flow reserve; and
displaying the first corrected fractional flow reserve.

2. The method of claim 1 , wherein the step of determining the geometric boundary of the second portion of the lumen closes a perimeter of the lumen.

3. The method of claim 1 , wherein the pressure measuring device is a pressure transducer in fluid communication with a purge port of the first intravascular probe in the vessel and wherein the pressure value is measured at a predetermined location near the purge port.

4. The method of claim 1 , further comprising determining the first fractional flow reserve by dividing a first pressure measured distal to a stenosis by a second pressure measured in an ostium.

5. The method of claim 4 , wherein the processor further calculates the first corrected fractional flow reserve by correcting the first fractional flow reserve using three dimensional hydrodynamic equations, including the microvascular resistance index, and the first geometric boundary the second geometric boundary.

6. The method of claim 1 , further comprising:
determining, using the processor, a second fractional flow reserve in the vessel;
correcting, using the processor, errors introduced by an obstruction in the vessel to determine a second corrected fractional flow reserve; and
comparing the first corrected fractional flow reserve and the second corrected fractional flow reserve.

7. The method of claim 6 , wherein the obstruction is the first intravascular probe, a second intravascular probe, a stenosis, a guidewire, or a stent.

8. The method of claim 6 , further comprising outputting a damage index in response to the step of comparing.

9. A method of determining one or more intravascular parameters of a blood vessel comprising:
optically measuring one or more pressure drops at one or more predetermined locations in the vessel;
determining, using intravascular image data of the vessel, a first geometric boundary of a first section of the vessel;
determining, based on the intravascular image data and the first geometric boundary, a second geometric boundary of a second portion of the lumen of the vessel different from the first portion, the second portion of the lumen being located behind a guidewire disposed within the blood vessel;
determining, based on the first geometric boundary and the second geometric boundary, a third geometric boundary of the guidewire, the third geometric boundary being located within the first geometric boundary and the second geometric boundary;
determining a mean area or a mean diameter profile for the section of the vessel using the geometric boundary;
determining one or more expected pressure drops using the mean area or mean diameter profile, wherein the determining includes iteratively correcting a hyperemic microvascular resistance index until a predefined error limit is reached, wherein the hyperemic microvascular resistance index is determined using a calculated pressure drop value;
determining a corrected fractional flow reserve value based on the hyperemic microvascular resistance index; and
displaying the corrected fractional flow reserve value using an optical coherence tomography system.

10. The method of claim 9 , further comprising displaying the hyperemic microvascular resistance index.

11. The method of claim 9 , further comprising determining an initial fractional flow reserve by dividing a first pressure measured distal to a stenosis by a second pressure measured in an ostium.

12. The method of claim 9 , wherein optically measuring the plurality of pressure values is performed distally relative to wherein the intravascular image data is obtained.

13. The method of claim 9 , wherein the corrected fractional flow reserve values is iteratively obtained such that one or more corrections are made to reduce errors associated with optical imaging and optical pressure sensing measurements.

14. A system comprising:
an intravascular probe disposed within a blood vessel;
a pressure measuring device;
one or more processors, the one or more processors configured to:
receive, from the intravascular probe, intravascular image data relating to the blood vessel;
determine a first geometric boundary of a first portion of a lumen of the vessel;
determine, based on the intravascular image and the first geometric boundary, a second geometric boundary of a second portion of the lumen of the vessel different from the first portion, the second portion of the lumen being located behind a guidewire disposed within the lumen;
determine, based on the first geometric boundary and the second geometric boundary, a third geometric boundary of the guidewire, the third geometric boundary being located within the first geometric boundary and the second geometric boundary;
measure, using the pressure measuring device disposed within the intravascular probe, one or more pressure values at one or more predetermined locations in the vessel;
determine based on the one or more pressure values, a first fractional flow reserve of the vessel;
iteratively correct a hyperemic microvascular resistance index until a predefined error limit is reached, wherein the hyperemic microvascular resistance index is determined using a calculated pressure drop value and the one or more pressure values, wherein the predefined error limit relates to the difference between the calculated pressure drop and the difference between the one or more pressure values;
calculate, based on the one or more pressure values and the corrected hyperemic microvascular resistance value, an estimated pressure drop associated with removal of the third geometric boundary from the vessel;
calculate, based on the estimated pressure drop, a first corrected fract

Assignees

• Lightlab Imaging Inc

Inventors

• Petroff Christopher
• Schmitt Joseph M

Classifications

• A61B2576/023

  for the heart · CPC title

• A61B5/7282

  Event detection, e.g. detecting unique waveforms indicative of a medical condition (cough events A61B5/0823; seizures A61B5/4094; sleep apnoea A61B5/4818) · CPC title

• A61B5/7278

  Artificial waveform generation or derivation, e.g. synthesizing signals from measured signals · CPC title

• A61B5/026

  Measuring blood flow {(A61B3/1233, A61B3/1241 take precedence)} · CPC title

• A61B5/02158

  provided with two or more sensor elements · CPC title