Combination sensor guidewire and methods of use

• US 8,231,537 B2
• Filed: 06/23/2006
• Issued: 07/31/2012
• Est. Priority Date: 09/27/2004
• Status: Active Grant

• Current Assignee: Volcano Corporation (Koninklijke Philips N.V.)
• Original Assignee: Volcano Corporation (Koninklijke Philips N.V.)
• Inventors: Ahmed, Masood, Oliver, Edward Anthony, Puleo, Joseph, Ingman, Christopher Dee, Walker, Blair D.
• Primary Examiner(s): Natnithithadha, Navin
• Application Number:
  US11/473,612
• Publication Number:
  US 20060241505A1
• Time in Patent Office: 2,230 Days
• Field of Search: 600/481, 600483-486, 600/488, 600500-507, 600/513, 600/508, 600/509, 600/547, 600/561, 600/585
• US Class Current: 600/485
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• 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 8/06 Measuring blood flow measuring volume flow in general G01F, e.g. G01F1/66, G01F1/72; measuring speed of fluids in general G01P5/00
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/445 Details of catheter construction

Abstract

The present invention provides for an improved combination sensor tip that includes a pressure sensor and a second sensor other than a pressure sensor, both disposed at or in close proximity to the distal end of the combination sensor tip. The present invention also provides for an improved connector to couple a guide wire to a physiology monitor that reduces torsional resistance when maneuvering the guide wire.

Claims

1. A method for measuring blood pressure and a blood flow characteristic other than blood pressure at a region of interest in a vessel without restricting flow in the vessel, comprising the steps of:

providing a flexible elongate member having a proximal end, a distal end, and an outer diameter of no greater than 0.018 inches, a pressure sensor secured to a distal region of the elongate member, and a sensor for measuring a blood flow characteristic other than blood pressure secured to the distal region of the elongate member, wherein the separation between the pressure sensor and the sensor for measuring a blood flow characteristic other than blood pressure is less than 3 cm;

advancing the distal end of the elongate member to the region of interest;

measuring blood pressure at the region of interest; and

measuring a blood flow characteristic other than blood pressure at the region of interest simultaneous with the step of measuring blood pressure,

wherein the region of interest comprises a vascular stenosis, and

wherein the step of measuring blood pressure at the region of interest comprises measuring a first blood pressure distal the stenosis in a first flow state and measuring a second blood pressure in a second flow state;

wherein the step of measuring a blood flow characteristic other than blood pressure at the region of interest comprises measuring a first blood flow characteristic other than blood pressure distal the stenosis in a first flow state and measuring a second blood flow characteristic other than blood pressure in a second flow state; and

wherein the method further comprises determining a severity of the stenosis by at least one of the following steps;

comparing the first blood pressure and the second blood pressure; and

comparing the first blood flow characteristic other than blood pressure and the second blood flow characteristic other than blood pressure.

2. The method of claim 1, further comprising the step of providing a control console, wherein the steps of obtaining measurements from the pressure sensor, obtaining measurements of the blood flow characteristic other than blood pressure, and analyzing the measurements are performed using the control console.

3. The method of claim 1, wherein the sensor for measuring a blood flow characteristic other than blood pressure is a flow velocity sensor.

4. A method for measuring blood pressure and a blood flow characteristic other than blood pressure at a region of interest in a vessel without restricting flow in the vessel, comprising the steps of:

providing a flexible elongate member having a proximal end, a distal end, and an outer diameter of no greater than 0.018 inches, a sensor secured to a distal region of the elongate member no more than 3 cm from the distal end;

advancing the distal end of the elongate member to the region of interest, wherein the region of interest comprises a vascular stenosis;

measuring blood pressure at the region of interest; and

measuring a blood flow characteristic other than blood pressure at the region of interest simultaneous with the step of measuring blood pressure,

wherein the step of measuring blood pressure at the region of interest comprises measuring a first blood pressure distal the stenosis in a first flow state and measuring a second blood pressure in a second flow state,

wherein the step of measuring a blood flow characteristic other than blood pressure at the region of interest comprises measuring a first blood flow characteristic other than blood pressure distal the stenosis in a first flow state and measuring a second blood flow characteristic other than blood pressure in a second flow state; and

wherein the method further comprises determining a severity of the stenosis by at least one of the following steps;

comparing the first blood pressure and the second blood pressure; and

comparing the first blood flow characteristic other than blood pressure and the second blood flow characteristic other than blood pressure.

5. The method of claim 4, further comprising the step of providing a control console, wherein the steps of obtaining measurements from the pressure sensor, obtaining measurements of a blood flow characteristic other than blood pressure, and analyzing the measurements are performed using the control console.

6. The method of claim 4, wherein the elongate member further comprises a second sensor.

7. The method of claim 6, wherein the second sensor is a flow velocity sensor.

8. The method of claim 7, wherein the second sensor is an ultrasound transducer.

9. The method of claim 7, wherein the second sensor is a Doppler flow sensor.

10. A method for measuring blood pressure and blood flow velocity at a region of interest in a vessel without restricting flow in the vessel, comprising the steps of:

providing a flexible elongate member having a proximal end, a distal end, and an outer diameter of no greater than 0.018 inches, a pressure sensor secured to a distal region of the elongate member, and a sensor for measuring blood flow velocity secured to a more distal region of the elongate member relative to the position of the pressure sensor;

advancing the distal end of the elongate member to the region of interest;

measuring blood pressure at the region of interest; and

measuring blood flow velocity at the region of interest simultaneous with the step of measuring blood pressure,

wherein the step of measuring blood pressure at the region of interest comprises measuring a first blood pressure in a first flow state and measuring a second blood pressure in a second flow state, and wherein the region of interest comprises a vascular stenosis;

wherein the step of measuring a blood flow velocity at the region of interest comprises measuring a first blood flow velocity in a first flow state and measuring a second blood flow velocity in a second flow state; and

wherein the method further comprises determining a severity of the stenosis by at least one of the following steps;

comparing the first blood pressure and the second blood pressure; and

comparing the first blood flow velocity and the second blood flow velocity.

11. The method of claim 10, further comprising the step of providing a control console, wherein the steps of obtaining measurements from the pressure sensor, obtaining measurements of blood flow velocity, and analyzing the measurements are performed using the control console.

12. The method of claim 10, wherein the step of advancing the distal end of the elongate member to the region of interest results in both sensors being positioned on a first side of the stenosis.

13. The method of claim 12, wherein the first side of the stenosis is a distal side of the stenosis.

14. The method of claim 12, further comprising the step of forming a combined P-V curve based on data received from measuring blood pressure at the region of interest and measuring the blood flow velocity at the region of interest.

15. The method of claim 10, further comprising the step of calculating a Fractional Flow Reserve (FFR) based on data received from measuring blood pressure at the region of interest and measuring the blood flow velocity at the region of interest.

16. The method of claim 10, further comprising the step of calculating a Coronary Flow Reserve (CFR) based on data received from measuring blood pressure at the region of interest and measuring the blood flow velocity at the region of interest.

17. A method for measuring blood pressure and blood flow velocity at a region of interest in a vessel, comprising the steps of:

simultaneously advancing a pressure sensor and a flow sensor to a region of a vessel adjacent a stenosis;

simultaneously measuring blood pressure and blood flow velocity at the region during a first flow state of blood within the vessel;

causing a second flow state of the blood within the vessel, the second flow state being different than the first flow state; and

simultaneously measuring blood pressure and blood flow velocity at the region during the second flow state.

18. The method of claim 17, wherein the region of interest is distal to the stenosis.

19. The method of claim 17, wherein the region of interest is proximal to the stenosis.

20. The method of claim 17, wherein the second flow state has an increased flow relative to the first flow state.

21. The method of claim 20, wherein the step of causing the second flow state comprises administering a drug to a patient.

22. The method of claim 20, further comprising calculating a Fractional Flow Reserve (FFR) based on data received from measuring the blood pressure and blood flow velocity during the first and second flow states.

23. The method of claim 20, further comprising the step of calculating a Coronary Flow Reserve (CFR) based on data received from measuring the blood pressure and blood flow velocity during the first and second flow states.

24. The method of claim 20, further comprising the step of forming a combined P-V curve based on data received from measuring the blood pressure and blood flow velocity during the first and second flow states.

25. A method for measuring blood pressure and a blood flow characteristic other than blood pressure at a region of interest in a vessel without restricting flow in the vessel, comprising the steps of:

providing a flexible elongate member having a proximal end, a distal end, and an outer diameter of no greater than 0.018 inches, a pressure sensor secured to a distal region of the elongate member, and a device for obtaining data representative of a vessel characteristic other than blood pressure secured to the distal region of the elongate member, wherein the separation between the pressure sensor and the device for obtaining data representative of a vessel characteristic other than blood pressure is less than 3 cm;

advancing the distal end of the elongate member to the region of interest;

measuring blood pressure at the region of interest with the pressure sensor during a first flow state of blood within the vessel;

obtaining data representative of a vessel characteristic other than blood pressure at the region of interest during the first flow state with the device for obtaining data representative of a vessel characteristic other than blood pressure;

causing a second flow state of the blood within the vessel, the second flow state being different than the first flow state; and

measuring blood pressure and obtaining data representative of a vessel characteristic other than blood pressure at the region of interest during the second flow state.

26. The method of claim 25, further comprising the step of providing a control console, wherein the steps of obtaining measurements from the pressure sensor, obtaining data representative of the vessel characteristic other than blood pressure, and analyzing the measurements and the data are performed using the control console.

27. The method of claim 25, wherein the region of interest comprises a vascular stenosis.

28. The method of claim 27, wherein the step of measuring blood pressure at the region of interest comprises measuring a first blood pressure distal the stenosis in a first flow state and measuring a second blood pressure in a second flow state;

wherein the step of obtaining data representative of the vessel characteristic other than blood pressure at the region of interest comprises obtaining a first data set representative of the vessel characteristic other than blood pressure distal the stenosis in a first flow state and obtaining a second data set representative of the vessel characteristic other than blood pressure in a second flow state; and

wherein the method further comprises determining a severity of the stenosis by at least one of the following steps;

comparing the first blood pressure and the second blood pressure; and

comparing the first data set representative of the vessel characteristic other than blood pressure and the second data set representative of the vessel characteristic other than blood pressure.

29. The method of claim 25, wherein the device for obtaining data representative of the vessel characteristic other than blood pressure is a flow velocity sensor.

30. The method of claim 25, wherein the device for obtaining data representative of the vessel characteristic other than blood pressure is an ultrasound transducer.

31. The method of claim 25, wherein the device for obtaining data representative of the vessel characteristic other than blood pressure is a Doppler flow sensor.

32. The method of claim 25, wherein the second flow state has an increased flow relative to the first flow state.

33. The method of claim 32, further comprising the step of calculating a Fractional Flow Reserve (FFR) based on the data received from measuring blood pressure at the region of interest and obtaining data representative of the vessel characteristic other than blood pressure at the region of interest during the first and second flow states.

34. The method of claim 32, further comprising the step of calculating a Coronary Flow Reserve (CFR) based on the data received from measuring blood pressure at the region of interest and obtaining data representative of the vessel characteristic other than blood pressure at the region of interest during the first and second flow states.