Method and system for pressure based measurements of CFR and additional clinical hemodynamic parameters

• US 6,471,656 B1
• Filed: 06/25/1999
• Issued: 10/29/2002
• Est. Priority Date: 06/25/1999
• Status: Expired due to Fees

• Current Assignee: Florence Medical Limited
• Original Assignee: Florence Medical Limited
• Inventors: Barak, Chen, Dgany, Elhanan, Noskowicz, Simon Henri, Shalman, Evgeny
• Primary Examiner(s): Nasser, Robert L.
• Application Number:
  US09/344,505
• Time in Patent Office: 1,222 Days
• Field of Search: 600/345, 600/366, 600/373-374, 600/381, 600/403, 600/410, 600/420, 600/431, 600/481, 600/483, 600/485-488, 600/504-505, 600/508, 600/513, 600/526, 600/561
• US Class Current: 600/486
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: A61B 5/6851 Guide wires

Abstract

The present invention relates to intravascular pressure measurement based devices and methods determining clinical parameters related to stenosis severity for improved clinical diagnosis and treatment of cardiovascular disease in blood vessels or tubular conduits. More specifically, the invention provides methods for the determination of the clinically significant well known Coronary Flow Reserve (CFR) parameter-previously acquired by velocity measurement devices. In addition Coronary Flow Reserve in the same vessel without stenosis may be estimated and uses to select the necessary medical treatment. Additional pressure based clinical parameters, Diastole to Systole Velocity Ratio (DSVR) and Fractional Flow Reserve (FFR) in stenotic blood vessel during intervention (using only pressure measurements across stenosis) may also be calculated simultaneously, with the same set of interventional devices. Correlation of CFR with these parameters (e.g. FFR) may be further used to estimate the stenosis severity, downstream stenosis and the condition of the vascular bed or conditions related to aneurysms. It is known that there is a correlation between CFR and FFR for healthy vascular bed. Too low value of CRF for given FFR indicates either downstream flow restriction or insufficient infusion of vasodilator. Too high value of CFR for given FFR indicates vascular bed disease.

Claims

1. A method for determination of coronary flow reserve in a stenotic vessel, the method comprising the steps of:

providing an apparatus adapted to measure pressure across a blood vessel obstruction; and

determining said coronary flow reserve from said pressure measurements.

2. The method of claim 1, further including the step of measuring aortic pressure and pressure distal to said obstruction simultaneously by said apparatus having a fluid filled manometer and a pressure transducer, respectively.

3. The method of claim 1, further including the steps of:

measuring aortic pressure with said apparatus having a fluid filled manometer;

measuring pressure across said obstruction with said apparatus having a moving pressure transducer; and

synchronizing said pressure measurements with said apparatus having an ECG.

4. The method of claim 1, further including the steps of:

measuring pressure across said obstruction with said apparatus having a moving pressure transducer; and

synchronizing said pressure measurements with said apparatus having an ECG.

5. The method of claim 1, further including the steps of:

measuring aortic pressure with said apparatus having a fluid filled manometer;

measuring pressure across said obstruction with said apparatus having a moving pressure transducer; and

synchronizing said pressure measurements with said moving pressure transducer.

6. The method of claim 1, further including the steps of:

measuring aortic pressure with said apparatus having a fluid filled manometer;

measuring pressure across said obstruction with said apparatus having a moving pressure transducer; and

synchronizing said pressure measurements with said fluid filled manometer.

7. The method of claim 1 wherein said obstruction is a natural stenosis.

8. The method of claim 1 wherein said obstruction is an artificial balloon obstruction.

9. A method for determination of coronary flow reserve in a blood vessel having an obstruction, the method including the steps of:

providing an apparatus adapted to measure pressure across said obstruction;

measuring pressures across said obstruction wherein an aortic pressure and a pressure distal to said obstruction are simultaneously measured by said apparatus having a fluid filled manometer and a pressure transducer, respectively; and

determining coronary flow reserve from said pressure measurements.

10. A method for determination of coronary flow reserve in a blood vessel having an obstruction, the method including the steps of:

providing an apparatus adapted to measure pressure across said obstruction;

measuring an aortic pressure with said apparatus having a fluid filled manometer for the aortic pressure;

measuring pressure across the obstruction with said apparatus having a moving pressure transducer; and

determining coronary flow reserve from said pressure measurements.

11. A method for determination of coronary flow reserve in a blood vessel having an obstruction, the method including the steps of:

providing an apparatus adapted to measure pressure across said obstruction;

measuring an aortic pressure with said apparatus having a fluid filled manometer for the aortic pressure;

measuring pressure across the obstruction with said apparatus having a moving pressure transducer;

synchronizing said pressure measurements with said apparatus having an ECG; and

determining coronary flow reserve from said pressure measurements.

12. A method for determination of coronary flow reserve in a blood vessel having an obstruction, the method including the steps of:

providing an apparatus adapted to measure pressure across said obstruction;

measuring an aortic pressure with said apparatus having a fluid filled manometer for the aortic pressure;

measuring pressure across said obstruction with said apparatus having a moving pressure transducer;

synchronizing said pressure measurements with said moving pressure transducer; and

determining coronary flow reserve from said pressure measurements.

13. A method for determination of coronary flow reserve in a blood vessel having an obstruction, the method including the steps of:

providing an apparatus adapted to measure pressure across said obstruction;

measuring an aortic pressure with said apparatus having a fluid filled manometer for the aortic pressure;

measuring pressure across the obstruction with said apparatus having a moving pressure transducer;

synchronizing said pressure measurements with said fluid filled manometer; and

determining coronary flow reserve from said pressure measurements.

14. A sensor apparatus for determination of coronary flow reserve in a stenotic vessel comprising:

at least one pressure sensor, wherein said at least one pressure sensor includes a plurality of pressure sensors adapted to measure pressure distal and proximal to an obstruction; and

a processor for determining coronary flow reserve from said pressure measurements.

15. A sensor apparatus for determination of coronary flow reserve in a stenotic vessel comprising:

at least one pressure sensor, wherein said at least one pressure sensor includes a fluid filled manometer and a pressure transducer adapted to simultaneously measure aortic pressure and pressure distal to said obstruction, respectively; and

a processor for determining coronary flow reserve from said pressure measurements.

16. A method for determination of diastole to systole velocity ratio in a stenotic vessel, the method comprising the steps of:

providing an apparatus adapted to measure pressure distal and proximal to a stenosis;

measuring aortic pressure with said apparatus having a fluid filled manometer;

measuring pressure across said stenosis with said apparatus having a moving pressure transducer;

synchronizing said pressure measurements with said apparatus having an ECG; and

determining diastole to systole velocity ratio from said pressure measurements.

17. A sensor apparatus for determination of coronary flow reserve in a stenotic vessel comprising:

at least one pressure sensor for obtaining pressure measurements, wherein said at least one pressure sensor comprises;

a fluid filled manometer adapted to measure aortic pressure; and

a pressure transducer adapted to measure pressure across said obstruction;

an ECG cooperatively connected to said at least one pressure sensor for synchronization of said pressure measurements; and

a processor for determining coronary flow reserve from said pressure measurements.

18. A sensor apparatus for determination of coronary flow reserve in a stenotic vessel comprising:

at least one pressure sensor for obtaining pressure signals, wherein said at least one pressure sensor includes a moving pressure transducer adapted to measure pressure across an obstruction;

an ECG cooperatively connected to said at least one pressure sensor for synchronization of said pressure signals; and

a processor for determining coronary flow reserve from said pressure signals.

19. A sensor apparatus for determination of coronary flow reserve in a blood vessel having an obstruction, the apparatus comprising:

at least one pressure sensor adapted to measure pressure across said obstruction, wherein said at least one pressure sensor comprises;

a fluid filled manometer adapted to measure aortic pressure; and

a pressure transducer adapted to measure pressure across said obstruction;

an ECG for synchronization of said pressure measurements; and

a processor for determining coronary flow reserve from said pressure measurements.

20. A sensor apparatus for determination of coronary flow reserve in a blood vessel having an obstruction, the apparatus comprising:

at least one pressure sensor adapted to measure pressure across said obstruction, wherein said at least one pressure sensor comprises;

a fluid filled manometer adapted to measure aortic pressure; and

a pressure transducer adapted to measure pressure across said obstruction,

wherein said pressure measurements are used for synchronization of said pressure measurements; and

a processor for determining coronary flow reserve from said pressure measurements.

21. A sensor apparatus for determination of coronary flow reserve in a blood vessel having an obstruction, the apparatus comprising:

at least one pressure sensor adapted to measure pressure across said obstruction, wherein said at least one pressure sensor comprises;

a fluid filled manometer adapted to measure aortic pressure; and

a pressure transducer adapted to measure pressure across said obstruction,

wherein said fluid filled manometer pressure measurements are used for synchronization of said pressure measurements; and

a processor for determining coronary flow reserve from said pressure measurements.

22. A sensor system comprising:

at least one sensor adapted to measure pressure in a tubular conduit across and obstruction; and

means for determining coronary flow reserve together with fractional flow reserve in the same blood vessel or tubular conduit without stenosis and analysis of their correlation.

23. A sensor system comprising:

at least one sensor adapted to measure pressure in a tubular conduit across and obstruction; and

means for determining coronary flow reserve together with fractional flow reserve in the same blood vessel without stenosis and analysis of their correlation for estimation of vascular bed conditions or an aneurysm.