INTRAVASCULAR PRESSURE DROP DERIVED ARTERIAL STIFFNESS AND REDUCTION OF COMMON MODE PRESSURE EFFECT

• US 20160000341A1
• Filed: 02/18/2014
• Published: 01/07/2016
• Est. Priority Date: 02/18/2013
• Status: Abandoned Application

• Current Assignee: Ramot at Tel Aviv University Limited (Tel Aviv University)
• Original Assignee: Ramot at Tel Aviv University Limited (Tel Aviv University)
• Inventors: EINAV, Shmuel, ROTMAN, Oren
• Application Number:
  US14/768,461
• Publication Number:
  US 20160000341A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2018/00404 Blood vessels other than those in or around the heart
• CPC Class Codes: A61B 2018/00434 Neural system
• CPC Class Codes: A61B 2018/00511 Kidney
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00642 with feedback, i.e. closed loop control
• CPC Class Codes: A61B 5/02007 Evaluating blood vessel condition, e.g. elasticity, compliance
• 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 5/7225 Details of analog processing, e.g. isolation amplifier, gain or sensitivity adjustment, filtering, baseline or drift compensation A61B5/30, A61B5/316 take precedence; transformers for specific applications H01F38/00; amplifiers H03F

Abstract

In some embodiments, a method and/or device are disclosed for measuring a pressure drop over a portion of a body lumen. Optionally, the pressure drop for two different flow conditions may be used to find the stiffness of the lumen. In some embodiments the device may be calibrated, for example by correcting for distortion, for example the common mode pressure distortion. Pressure drop and or stiffness measures may be used to evaluate a treatment procedure and/or a stenosis.

Claims

1. A system for measuring stiffness of a body lumen comprising:

a probe including two measuring locations;

a pressure gauge, that generates a signal indicative of the differential pressure between said measurement locations; and

a controller, adapted to compute a pressure drop between said measuring locations based on the signal of the pressure gauge, for each of at least two different flow conditions, and to find a relative stiffness of the body lumen from the pressure drops.

2. The system of claim 1, further comprising:

a pressure-measuring catheter including;

a fluid-filled first lumen and wherein a first of said measurement locations includes an opening from said first lumen to an outside surface of the pressure-measuring catheter and the pressure measuring catheter also includes

a fluid-filled second lumen, and wherein a second of said measurement locations includes an opening from said second lumen to the outside surface of the pressure-measuring catheter, both said openings being inside the body lumen when the pressure-measuring catheter is inserted, the opening of the first lumen being more distal than the opening of the second lumen, and both said first lumen and said second lumen having proximal ends outside the body when the pressure-measuring catheter is inserted;

and wherein said pressure gauge measures a pressure differential at one or more of the proximal ends of the first and second lumens and said signal depends on said measured pressure differential.

3. The system of claim 1, wherein said body lumen is a blood vessel and the pressure-measuring catheter is configured for insertion into the blood vessel, and wherein said controller is adapted to find a pressure drop from the differential pressure signal for said at least two different flow conditions including at least two different phases of a cardiac cycle, and wherein said controller is adapted to find said relative stiffness from the pressure drops of said at least two different phases.

4. The system of claim 1, also comprising a flow sensor adapted to generate a signal indicative of flow in said body lumen, and wherein the controller is adapted to use the signal indicative of flow, obtained for the at least two flow conditions, to find an absolute stiffness of the body lumen from the pressure drops.

5. The system according to claim 1, also comprising a sleeve that surrounds the pressure-measuring catheter, the pressure-measuring catheter being adapted to withdraw into and extend out of the sleeve when it is inserted into the body lumen, wherein the controller is adapted to discern a distortion of the signal generated by the pressure gauge when the pressure-measuring catheter is withdrawn into the sleeve.

6. The system according to claim 1, also comprising a sleeve that surrounds the pressure-measuring catheter, the pressure-measuring catheter being adapted to withdraw into and extend out of the sleeve when it is inserted into the body lumen, wherein the controller is adapted to discern a distortion of the signal generated by the pressure gauge when the pressure-measuring catheter is withdrawn into the sleeve, wherein said sleeve includes a delivery catheter.

7. The system according to claim 1, also comprising a sleeve that surrounds the pressure-measuring catheter, the pressure-measuring catheter being adapted to withdraw into and extend out of the sleeve when it is inserted into the body lumen, wherein the controller is adapted to discern a distortion of the signal generated by the pressure gauge when the pressure-measuring catheter is withdrawn into the sleeve, wherein said sleeve includes a delivery catheter and wherein said controller is further configured to calculate a correction for said distortion to the signal and to apply said correction for said distortion to the signal generated by the pressure gauge when the pressure-measuring catheter is exposed to the flow in said body lumen, said correction based on a result of said discerning.

8. The system according to claim 1, also comprising a sleeve that surrounds the pressure-measuring catheter, the pressure-measuring catheter being adapted to withdraw into and extend out of the sleeve when it is inserted into the body lumen, wherein the controller is adapted to discern a distortion of the signal generated by the pressure gauge when the pressure-measuring catheter is withdrawn into the sleeve, wherein said distortion includes a common mode pressure distortion.

9. The system of claim 1, wherein a distance between said measuring locations is no more than 5 cm.

10. The system of claim 2, wherein each said opening of said first and second openings is substantially at a distal end of each respective said lumen of the catheter.

11. The system of claim 2, further comprising an interventional device for performing a treatment intervention on said body lumen and wherein said pressure-measuring catheter is used for at least one of verifying and monitoring said treatment intervention.

12. The system of claim 2, further comprising an interventional device for performing a treatment intervention on said body lumen and wherein said pressure-measuring catheter is used for at least one of verifying and monitoring said treatment intervention, and wherein said interventional device includes an ablation device.

13. The system of claim 1, wherein said controller is adapted to compute said pressure drop to an accuracy to within 0.1 mmHg.

14. A system according to claim 1, wherein said pressure gauge includes a differential pressure gauge.

15. A method of measuring stiffness of a blood vessel in a subject, the method comprising:

measuring a pressure drop across substantially the same portion of the blood vessel, for each of at least two different flow conditions; and

analyzing the measured pressure drops to determine a relative stiffness of the blood vessel.

18. A method according to claim 15, also comprising measuring the pressure drop for each of at least two flow conditions across at least another portion along the blood vessel, and analyzing the measured pressure drops to determine at least a relative stiffness comprises comparing the pressure drops measured across said same portion and said at least another portion to determine the relative stiffness, wherein said same portion and said at least another portion have one of the same length and different lengths.

21. A method according to claim 15, also comprising evaluating a reduction in blood flow caused by the resistance in the same portion based on the pressure drop.

23. A method according to claim 15, also comprising measuring a blood flow rate in the blood vessel at two different phases of a cardiac cycle, and analyzing the measured pressure drops comprises also using the measured blood flow rates and determining an absolute stiffness.

26. A method according to claim 15, also comprising using the determined stiffness to locate or evaluate one or more of a stenosis, a sclerotic lesion, and vulnerable plaque.

29. A method according claim 15, also comprising assessing an interventional treatment based on the determined stiffness, wherein said interventional treatment is of a renal denervation.

42. The method according to claim 15, wherein said measuring includes:

inserting a probe into a first region of fluid with a time-varying gauge pressure but negligible pressure drop between the sensing locations;

measuring an indicator of the time-varying gauge pressure in the first region;

sensing said pressure drop under the time-varying gauge pressure in the first region, and

inserting the catheter into a second region of fluid with a pressure drop between said sensing locations;

measuring the indicator of time-varying gauge pressure in the second region; and

sensing the pressure drop in the second region; and

said method further includes correcting a distortion of differential pressure between two sensing locations, comprising;

finding a restoration function of the indicator of time-varying gauge pressure in the first region for an output signal of said sensing in said first region; and

transforming an output signal of said sensing in the second region with the restoration function and a function of the measured indicator of time-varying gauge pressure to obtain a corrected pressure drop in the second region, wherein said transforming results in the corrected pressure that is accurate to within 0.05 mmHg.

43. The method according to claim 15, wherein said measuring includes:

inserting a probe into a first region of fluid with a time-varying gauge pressure but negligible pressure drop between the sensing locations;

measuring an indicator of the time-varying gauge pressure in the first region;

sensing said pressure drop under the time-varying gauge pressure in the first region, and

inserting the catheter into a second region of fluid with a pressure drop between said sensing locations;

measuring the indicator of time-varying gauge pressure in the second region,

sensing the pressure drop in the second region; and

said method further includes correcting a distortion of differential pressure between two sensing locations, comprising;

finding a restoration function of the indicator of lime-varying gauge pressure in the first region for an output signal of said sensing in said first region; and

transforming an output signal of said sensing in the second region with the restoration function and a function of the measured indicator of time-varying gauge pressure to obtain a corrected pressure drop in the second region;

wherein the restoration function transforms the indicator of gauge pressure to a linear combination of a finite number of terms selected from at least the one of the indicator, a first order time derivative of the indicator, a higher order derivative of the indicator, a linear function of the gauge pressure, a derivative of the liner function of the gauge pressure and a higher order derivative of the linear function of the gauge pressure.

45. The method according to claim 15, wherein said measuring includes:

inserting a probe into a first region of fluid with a time-varying gauge pressure but negligible pressure drop between the sensing locations;

measuring an indicator of the time-varying gauge pressure in the first region;

sensing said pressure drop under the time-varying gauge pressure in the first region, and

inserting the catheter into a second region of fluid with a pressure drop between said sensing locations;

measuring the indicator of time-varying gauge pressure in the second region,

sensing the pressure drop in the second region; and

said method further includes correcting a distortion of differential pressure between two sensing locations, comprising;

finding a restoration function of the indicator of time-varying gauge pressure in the first region for an output signal of said sensing in said first region; and

transforming an output signal of said sensing in the second region with the restoration function and a function of the measured indicator of time-varying gauge pressure to obtain a corrected pressure drop in the second region;

extending the probe out of the first to the second region wherein the second region is an interior of the body lumen, and the first region is a region with negligible flow.

16-17. -17. (canceled)

19-20. -20. (canceled)

22. (canceled)

24-25. -25. (canceled)

27-28. -28. (canceled)

30-34. -34. (canceled)

35. The system of claim 130, wherein said controller is adapted to compute a Fractional Flow Reserve indicator.

36-41. -41. (canceled)

44. (canceled)

46-49. -49. (canceled)

50. A compound device for measuring a pressure drop in a body lumen in-vivo comprising:

a probe of a pressure drop between two sensing locations;

a sleeve that surrounds the pressure-measuring probe when it is inserted into the blood vessel, the pressure-measuring catheter being adapted to withdraw into and extend out of the sleeve;

a sensor generate a signal indicative the pressure drop between said sensing locations; and

a controller adapted to discern a distortion of said signal generated when the probe is surrounded by the sleeve.

51-53. -53. (canceled)