Devices, Systems, and Methods for Assessing a Vessel

• US 20140135633A1
• Filed: 01/16/2014
• Published: 05/15/2014
• Est. Priority Date: 08/20/2011
• Status: Active Grant

• Current Assignee: Volcano Corporation (Koninklijke Philips N.V.)
• Original Assignee: Volcano Corporation (Koninklijke Philips N.V.)
• Inventors: Anderson, David, Alpert, Howard David
• Granted Patent: US 10,888,232 B2
• Time in Patent Office: Days
• US Class Current: 600/486
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• CPC Class Codes: A61B 5/02 Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
• CPC Class Codes: A61B 5/02007 Evaluating blood vessel condition, e.g. elasticity, compliance
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/02158 provided with two or more sensor elements
• CPC Class Codes: A61B 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: A61B 5/6851 Guide wires
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61B 5/743 Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots

Abstract

Embodiments of the present disclosure are configured to assess the severity of a blockage in a vessel and, in particular, a stenosis in a blood vessel. In some particular embodiments, the devices, systems, and methods of the present disclosure are configured to assess the severity of a stenosis in the coronary arteries without the administration of a hyperemic agent. Further, in some implementations devices, systems, and methods of the present disclosure are configured to normalize and/or temporally align pressure measurements from two different pressure sensing instruments. Further still, in some instances devices, systems, and methods of the present disclosure are configured to exclude outlier cardiac cycles from calculations utilized to evaluate a vessel, including providing visual indication to a user that the cardiac cycles have been excluded.

Claims

1. A method of evaluating a vessel of a patient, comprising:

obtaining pressure measurements from first and second pressure sensing instruments while the first and second pressure sensing instruments are positioned within the vessel of the patient and adjacent to one another; and

normalizing the pressure measurements of the first and second pressure sensing instruments to one another utilizing at least one cardiac cycle following activation of a normalization button by a user.

2. The method of claim 1, wherein the least one cardiac cycle includes at least three cardiac cycles.

3. The method of claim 2, wherein the least one cardiac cycle includes five cardiac cycles.

4. The method of claim 1, wherein normalizing the pressure measurements includes calculating a normalization adjustment using an average of more than one sample.

5. The method of claim 4, wherein the average is calculated for more than 500 samples of the pressure measurements.

6. The method of claim 1, wherein the first pressure sensing instrument is a guidewire.

7. The method of claim 6, wherein normalizing the pressure measurements includes adjusting the pressure measurements of the first pressure sensing instrument to match those of the second pressure sensing instrument.

8. The method of claim 1, further comprising temporally aligning the pressure measurements of the first and second pressure sensing instruments.

9. The method of claim 8, wherein temporally aligning the pressure measurements includes calculating a time shift between the pressure measurements of the first pressure sensing instrument and the pressure measurements of the second pressure sensing instrument.

10. The method of claim 9, wherein the time shift is calculated using a cross-correlation function.

11. A system comprising:

a first pressure sensing instrument sized and shaped for introduction into a vessel of the patient;

a second pressure sensing instrument sized and shaped for introduction into the vessel of the patient;

a processing unit in communication with the first and second instruments, the processing unit configured to;

obtain pressure measurements from the first and second pressure sensing instruments while the first and second pressure sensing instruments are positioned within the vessel of the patient and adjacent to one another; and

normalizing the pressure measurements of the first and second pressure sensing instruments to one another utilizing at least one cardiac cycle following activation of a normalization button by a user.

12. The system of claim 11, wherein the least one cardiac cycle includes at least three cardiac cycles.

13. The system of claim 12, wherein the least one cardiac cycle includes five cardiac cycles.

14. The system of claim 11, wherein normalizing the pressure measurements includes calculating a normalization adjustment using an average of more than one sample.

15. The system of claim 14, wherein the average is calculated for more than 500 samples of the pressure measurements.

16. The system of claim 11, wherein the first pressure sensing instrument is a guidewire.

17. The system of claim 16, wherein normalizing the pressure measurements includes adjusting the pressure measurements of the first pressure sensing instrument to match those of the second pressure sensing instrument.

18. The system of claim 11, wherein the processing system is further configured to temporally align the pressure measurements of the first and second pressure sensing instruments.

19. The system of claim 18, wherein temporally aligning the pressure measurements includes calculating a time shift between the pressure measurements of the first pressure sensing instrument and the pressure measurements of the second pressure sensing instrument.

20. The system of claim 19, wherein the time shift is calculated using a cross-correlation function.

21. A method of evaluating a vessel of a patient, comprising:

obtaining pressure measurements from at least one pressure sensing instrument while the at least one pressure sensing instrument is positioned within the vessel of the patient over a plurality of cardiac cycles;

identifying an outlier cardiac cycle from the plurality of cardiac cycles;

excluding the identified outlier cardiac cycle from calculations; and

displaying the obtained pressure measurements to a user, wherein the display of the obtained pressure measurements identifies the outlier cardiac cycle.

22. The method of claim 21, wherein identifying the outlier cardiac cycle from the plurality of cardiac cycles includes analyzing the obtained pressure measurements to identify the outlier cardiac cycle.

23. The method of claim 22, wherein analyzing the obtained pressure measurements includes comparing the obtained pressure measurements to a threshold.

24. The method of claim 23, wherein the threshold is a relative change in pressure ratio compared to at least one of the other cardiac cycles.

25. The method of claim 23, wherein the threshold is a relative change in pressure ratio compared to an average of at least two of the other cardiac cycles.

26. The method of claim 21, wherein the display of the obtained pressure measurements identifies the outlier cardiac cycle utilizing text.

27. The method of claim 21, wherein the display of the obtained pressure measurements identifies the outlier cardiac cycle utilizing a distinguishable color.

28. The method of claim 21, wherein the display of the obtained pressure measurements identifies the outlier cardiac cycle by omitting the pressure measurements for the outlier cardiac cycle from the display.

29. The method of claim 21, (no wave free period for cardiac cycle:

based on landmarks (ECG criteria, not sufficient time)