Calibration of in vivo blood pressure sensors

• US 7,722,544 B2
• Filed: 10/17/2007
• Issued: 05/25/2010
• Est. Priority Date: 10/17/2007
• Status: Active Grant

• Current Assignee: Datascope Corporation (Getinge AB)
• Original Assignee: Datascope Corporation (Getinge AB)
• Inventors: Leschinsky, Boris, Daftary, Shrenik, Williams, Jonathan
• Primary Examiner(s): Nasser; Robert L
• Assistant Examiner(s): D'ANGELO, MICHAEL J
• Application Number:
  US11/975,055
• Publication Number:
  US 20090105598A1
• Time in Patent Office: 951 Days
• Field of Search: 600/485, 600/486, 600/500, 600/504, 600/505, 600/435
• US Class Current: 600/486
• CPC Class Codes: A61B 5/02156 Calibration means
• CPC Class Codes: A61M 2025/0002 with a pressure sensor at the distal end
• CPC Class Codes: A61M 25/10185 Valves

Abstract

A method for performing an in-vivo calibration of a blood pressure sensor that is associated with an in-vivo balloon system. The method involves monitoring a patient'"'"'s blood pressure by observing the system gas pressure while at the same time monitoring the patient'"'"'s blood pressure through the sensor. The blood pressure measurements obtained by monitoring the system gas pressure are used as reference, or “true,” blood pressure measurements, and an “offset” is determined between the reference blood pressure measurements and the blood pressure measurements obtained through the sensor. The offset can be stored in a memory, which may also store sensor sensitivity data. The offset and/or sensitivity data may be used to adjust future measurements obtained from the sensor, thereby generating calibrated sensor measurements.

Claims

1. A method for performing an in-vivo calibration of a blood pressure sensor that is associated with a balloon of an in-vivo balloon system, the sensor and balloon being associated such that the sensor is in vivo when the balloon is in-vivo, the method comprising the steps of:

controlling the inflation state of the balloon so that a gas pressure in the balloon system is indicative of a patient'"'"'s blood pressure, the controlling including slowing a normal inflation and/or deflation process associated with cardiac assist such that assist is not suspended and there is no need to remove gas from the system and no need to restore removed gas;

monitoring the patient'"'"'s blood pressure by observing the gas pressure while simultaneously monitoring the patient'"'"'s blood pressure through the sensor;

using blood pressure readings obtained by monitoring the gas pressure as reference blood pressure measurements and generating correction data based on the relationship between blood pressure measurements obtained through the sensor and the reference blood pressure measurements;

storing the correction data in a memory; and

modifying further blood pressure measurements obtained through the sensor according to the stored correction data in combination with additional correction data so as to generate calibrated blood pressure measurements.

2. The method as recited in claim 1, wherein the correction data comprises an offset correction.

3. The method as recited in claim 2, wherein the offset correction is set to the average difference between the level of the blood pressure measurements obtained through the sensor and the level of the reference blood pressure measurements.

4. The method as recited in claim 1, wherein the additional correction data comprises sensitivity correction data.

5. The method as recited in claim 1, wherein the additional correction data is also stored in the memory.

6. The method as recited in claim 1, wherein the step of controlling the inflation state of the balloon comprises partially inflating the balloon and not fully inflating the balloon.

7. The method as recited in claim 1, wherein the step of controlling the inflation state of the balloon comprises slowly inflating the balloon.

8. The method as recited in claim 1, wherein the step of controlling the inflation state of the balloon comprises slowly deflating the balloon.

9. The method as recited in claim 1, further comprising the steps of:

determining a target deflation pressure for the balloon; and

setting a gas pressure in the balloon system to the target deflation pressure before controlling the inflation state of the balloon.

10. The method as recited in claim 9, wherein the step of determining a target deflation pressure comprises the step of calculating a dead volume of the balloon system.

11. The method as recited in claim 9, wherein the step of determining a target deflation pressure comprises the step of reading an indication of a dead volume of the balloon system from a memory.

12. The method as recited in claim 1, wherein the step of monitoring comprises the step of recording a pressure signal generated by a gas pressure sensor and a pressure signal generated by the blood pressure sensor.

13. The method as recited in claim 12, wherein both the pressure signal generated by the gas pressure sensor and the pressure signal generated by the blood pressure sensor are made up of periodic samples.

14. The method as recited in claim 13, wherein the correction data comprises an offset correction, and wherein the offset correction is set to the average of the differences between corresponding pairs of samples of the pressure signal generated by the gas pressure sensor and the pressure signal generated by the blood pressure sensor.

15. The method as recited in claim 1, wherein the step of monitoring comprises the step of recording a pressure signal generated by a gas pressure sensor and a pressure signal generated by the blood pressure sensor, and the step of using comprises the step of performing a time-alignment of the pressure signal generated by the gas pressure sensor and the pressure signal generated by the blood pressure sensor.

16. The method as recited in claim 15, wherein the step of performing a time-alignment comprises the steps of correlating the pressure signal generated by the blood pressure sensor and the pressure signal generated by the gas pressure sensor to determine a relative time delay between the pressure signal generated by the blood pressure sensor and the pressure signal generated by the gas pressure sensor, and generating a time-shifted signal by time-shifting the pressure signal generated by the blood pressure sensor to compensate for the relative time delay.

17. The method as recited in claim 16, wherein the pressure signal generated by the gas pressure sensor, the pressure signal generated by the blood pressure sensor, and the time-shifted signal are made up of periodic samples, and the step of using correction data comprises the step of performing a sorting process on the pressure signal generated by the blood pressure sensor and the time-shifted signal.

18. The method as recited in claim 1, wherein the step of controlling the inflation state of the balloon comprises the step of inflating the balloon over a period of time such that the gas pressure in the balloon system is indicative of the patient'"'"'s blood pressure for a portion of the period.

19. The method as recited in claim 18, wherein the step of using comprises the step of determining a selected time interval within which the gas pressure in the balloon system is substantially indicative of the patient'"'"'s blood pressure.

20. The method as recited in claim 19, wherein the step of determining comprises the step of performing a correlation.

21. The method as recited in claim 19, wherein the step of determining comprises the step of comparing peak pulse amplitudes of blood pressure readings obtained by monitoring the gas pressure to peak pulse amplitudes of blood pressure measurements obtained through the sensor.

22. The method as recited in claim 1, wherein the step of controlling the inflation state of the balloon comprises the step of deflating the balloon over a period of time such that the gas pressure in the balloon system is indicative of the patient'"'"'s blood pressure for a portion of the period.

23. The method as recited in claim 22, wherein the step of using comprises the step of determining a selected time interval within which the gas pressure in the balloon system is substantially indicative of the patient'"'"'s blood pressure.

24. The method as recited in claim 23, wherein the step of determining comprises the step of performing a correlation.

25. The method as recited in claim 23, wherein the step of determining comprises the step of comparing peak pulse amplitudes of blood pressure readings obtained by monitoring the gas pressure to peak pulse amplitudes of blood pressure measurements obtained through the sensor.