Calibration of in vivo blood pressure sensors

• US 8,038,623 B2
• Filed: 03/25/2010
• Issued: 10/18/2011
• Est. Priority Date: 10/17/2007
• Status: Active Grant

• Current Assignee: Datascope Corporation (Getinge AB)
• Original Assignee: Datascope Corporation (Getinge AB)
• Inventors: Daftary, Shrenik, Williams, Jonathan, Leschinsky, Boris
• Primary Examiner(s): Mallari; Patricia
• Assistant Examiner(s): D'ANGELO, MICHAEL J
• Application Number:
  US12/661,840
• Publication Number:
  US 20100191129A1
• Time in Patent Office: 572 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. An apparatus for performing an in-vivo calibration of a blood pressure sensor that is associated with a balloon of an in-vivo balloon system, comprising:

a drive unit configured to control at least one of an inflation state and a deflation state of the balloon, the control comprising slowing a normal inflation and/or deflation process associated with cardiac assist such that the balloon transitions through a state in which a gas pressure in the balloon system is indicative of a patient'"'"'s blood pressure without suspending the inflation or deflation of the balloon; and

a processing unit configured to monitor the patient'"'"'s blood pressure by observing the gas pressure in the balloon system while simultaneously monitoring the patient'"'"'s blood pressure through the sensor, and configured to use the blood pressure readings obtained by monitoring the gas pressure to correct the blood pressure measurements obtained through the sensor.

2. The apparatus as recited in claim 1, wherein the sensor and the balloon are associated such that the sensor is in-vivo when the balloon is in-vivo.

3. The apparatus as recited in claim 1, wherein the blood pressure readings obtained by monitoring the gas pressure are used as reference blood pressure measurements and the processing unit is configured to generate correction data based on the relationship between the blood pressure measurements obtained through the sensor and the reference blood pressure measurements.

4. The apparatus as recited in claim 3, wherein the processing unit modifies further blood pressure measurements obtained through the sensor according to the correction data in combination with additional correction data so as to generate calibrated blood pressure measurements.

5. The apparatus as recited in claim 4, wherein the additional correction data comprises sensitivity correction data.

6. The apparatus as recited in claim 3, wherein the correction data comprises an offset correction.

7. The apparatus as recited in claim 1, wherein monitoring the patient'"'"'s blood pressure comprises recording a pressure signal generated by a gas pressure sensor and a pressure signal generated by the blood pressure sensor.

8. The apparatus as recited in claim 7, 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.

9. The apparatus as recited in claim 1, wherein monitoring the patient'"'"'s blood pressure comprises recording a pressure signal generated by a gas pressure sensor and a pressure signal generated by the blood pressure sensor, and using blood pressure readings comprises performing a time-alignment of the pressure signal generated by the gas pressure sensor and the pressure signal generated by the blood pressure sensor.

10. The apparatus as recited in claim 1, wherein using blood pressure readings comprises:

determining a selected time interval within which the gas pressure in the balloon system is substantially indicative of the patient'"'"'s blood pressure.

11. The apparatus as recited in claim 10, wherein determining selected time interval comprises determining peak amplitudes of pulses of the gas pressure and the blood pressure, computing the ratio of the peak amplitudes of the pulses of the gas pressure and the blood pressure, and setting the selected time interval to a time interval in which the computed ratios exceed a predetermined threshold.

12. The apparatus as recited in claim 1, wherein the drive unit is configured to maintain the gas pressure in the balloon system during monitoring.

13. The apparatus as recited in claim 1, wherein the processing unit is configured to monitor the pressures without removing shuttle gas from the balloon system during calibration.

14. An intra-aortic balloon pump comprising:

a drive unit configured to communicate with an intra-aortic balloon catheter, the intra-aortic balloon catheter being connected to a balloon, the drive unit configured to control an inflation and deflation of the balloon, and the control comprising slowing a normal inflation and/or deflation process associated with cardiac assist, and

a processing unit configured to monitor a patient'"'"'s blood pressure by monitoring the pressure within the balloon without suspending the inflation or deflation of the balloon.

15. The intra-aortic balloon pump of claim 14, wherein the intra-aortic balloon pump includes an associated blood pressure sensor, and

wherein the processing unit is configured to correct blood pressure measurements from the blood pressure sensor based on the patient'"'"'s blood pressure as monitored by monitoring the pressure within the balloon.

16. The intra-aortic balloon pump as recited in claim 15, wherein the sensor and the balloon are associated such that the sensor is in-vivo when the balloon is in-vivo.

17. The intra-aortic balloon pump as recited in claim 15, wherein blood pressure readings obtained by monitoring the pressure within the balloon are used as reference blood pressure measurements and the processing unit is configured to generate correction data based on the relationship between blood pressure measurements obtained through the sensor and the reference blood pressure measurements.

18. The apparatus as recited in claim 14, wherein the drive unit is configured to control the pressure in the balloon to remain between an assist pressure of the inflation state and an assist pressure of the deflation state during monitoring.

19. The apparatus as recited in claim 14, wherein the processing unit is configured to monitor the pressures without removing shuttle gas from the balloon pump during calibration.

20. The apparatus as recited in claim 15, wherein monitoring the patient'"'"'s blood pressure comprises recording a pressure signal generated by a gas pressure sensor and a pressure signal generated by the blood pressure sensor, and determining a selected time interval within which a gas pressure in the balloon system is substantially indicative of the patient'"'"'s blood pressure, and

wherein determining the selected time interval comprises determining peak amplitudes of pulses of the gas pressure and the blood pressure, computing the ratio of the peak amplitudes of the pulses of the gas pressure and the blood pressure, and setting the selected time interval to a time interval in which the computed ratios exceed a predetermined threshold.