Blood flow reestablishment determination

• US 6,979,293 B2
• Filed: 12/16/2002
• Issued: 12/27/2005
• Est. Priority Date: 12/14/2001
• Status: Active Grant

• Current Assignee: EKOS Corporation (Boston Scientific Corporation)
• Original Assignee: EKOS Corporation (Boston Scientific Corporation)
• Inventors: Volz, Kim R., Hansmann, Douglas R., Wilcox, Robert L., Peskin, Natalya, Karp, Floyd
• Primary Examiner(s): IMAM, ALI M
• Application Number:
  US10/320,847
• Publication Number:
  US 20030220568A1
• Time in Patent Office: 1,107 Days
• Field of Search: 601 2- 4, 600/439, 606/128, 606/169, 604/22
• US Class Current: 600/439
• CPC Class Codes: A61B 17/22012 in direct contact with, or very close to, the obstruction or concrement for removing obstructions in blood vessels by laser A61B18/245
• CPC Class Codes: A61B 2017/00057 Light
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00101 using an array of thermosensors
• CPC Class Codes: A61B 2017/22021 electric leads passing through the catheter
• CPC Class Codes: A61B 2017/22082 after introduction of a substance
• CPC Class Codes: A61B 2017/22084 stone- or thrombus-dissolving

Abstract

A method for monitoring a clot dissolution treatment in a patient'"'"'s vasculature comprises positioning a catheter at a treatment site in the patient'"'"'s vasculature. The method further comprises performing a clot dissolution treatment at the treatment site. The clot dissolution treatment comprises delivering ultrasonic energy and a therapeutic compound from the catheter to the treatment site such that a clot located at the treatment site at least partially dissolves. The method further comprises delivering a thermal measurement signal from a first portion of the catheter to the treatment site during the clot dissolution treatment. The method further comprises receiving the thermal measurement signal at a second portion of the catheter. The method further comprises comparing the delivered thermal measurement signal with the received thermal measurement signal to evaluate a blood flow rate at the treatment site.

Claims

1. A method for monitoring clot dissolution in a patient'"'"'s vasculature, the method comprising:

(a) positioning a catheter at a treatment site in the patient'"'"'s vasculature;

(b) performing a clot dissolution treatment procedure at the treatment site, wherein the clot dissolution treatment procedure comprises delivering ultrasonic energy and a therapeutic compound from the catheter to the treatment site;

(c) delivering a thermal measurement signal from a first portion of the catheter to the treatment she during the clot dissolution treatment;

(d) receiving the thermal measurement signal at a second portion of the catheter;

(e) comparing the delivered thermal measurement signal with the received thermal measurement signal to evaluate a blood flow rate at the treatment site; and

(f) using the blood flow rate to adjust the clot dissolution treatment.

2. The method of claim 1, further comprising repeating steps (c) and (d) a plurality of times.

3. The method of claim 2, further comprising:

creating a profile of the temperature at the treatment site during the clot dissolution treatment; and

comparing the profile with at least one reference profile to further evaluate a blood flow rate at the treatment site.

4. The method of claim 1, wherein the thermal measurement signal is delivered from an ultrasound radiating member positioned within the catheter.

5. The method of claim 4, wherein the thermal measurement signal is received at an ultrasound radiating member positioned within the catheter.

6. The method of claim 4, wherein the thermal measurement signal is received at a temperature sensor.

7. The method of claim 1, wherein the delivered thermal measurement signal is a periodic increased temperature pulse.

8. The method of claim 1, wherein the delivered thermal measurement signal is an oscillating thermal signal.

9. The method of claim 8, wherein step (e) comprises measuring the phase difference between the delivered thermal measurement signal and the received thermal measurement signal.

10. A method comprising:

positioning a catheter at a treatment site in a patient'"'"'s vasculature, wherein a blockage is located at the treatment site;

performing a medical treatment at the treatment site, the medical treatment configured to reduce the blockage;

making a plurality of thermal energy measurements at the treatment site while the medical treatment is being performed;

evaluating the reduction in the blockage based on the plurality of thermal energy measurements; and

adjusting the medical treatment based on the evaluation of the reduction in the blockage.

11. The method of claim 10, wherein the catheter comprises a plurality of ultrasound radiating members and a fluid delivery lumen configured to have a cooling fluid pass therethrough.

12. The method of claim 11, wherein the plurality of thermal energy measurements are made using a thermocouple.

13. The method of claim 12, wherein the thermocouple is positioned within the fluid delivery lumen, such that the thermocouple measures the temperature of the cooling fluid passing therethrough.

14. The method of claim 10, wherein the medical treatment comprises delivering ultrasonic energy to the treatment site.

15. The method of claim 14, wherein adjusting the medical treatment comprises adjusting the position of an ultrasound radiating member relative to the blockage.

16. The method of claim 10, wherein the medical treatment comprises delivering ultrasonic energy and a therapeutic compound to the treatment site.

17. An ultrasound catheter for evaluating the efficacy of a clot dissolution treatment, the catheter comprising:

an upstream region;

a downstream region located opposite the upstream region;

a treatment zone partially extending into both the upstream region and the downstream region;

an ultrasonic assembly positioned within the treatment zone, the ultrasonic assembly comprising at least one ultrasound radiating member configured to perform a clot dissolution treatment;

a thermal energy source positioned on the catheter, the thermal energy source configured to deliver a thermal measurement signal to the treatment zone during the clot dissolution treatment;

a thermal energy detector positioned on the catheter, the thermal energy detector configured to receive the thermal measurement signal from the treatment zone;

control circuitry configured to compare the thermal measurement signal delivered from the thermal energy source to the thermal measurement signal received at the thermal energy detector, the control circuitry further comprising an algorithm for calculating a change in blood flow rate based on the comparison; and

a user interface to display the blood flow rate, whereby the clot dissolution treatment may be adjusted.

18. The catheter of claim 17, wherein the catheter further comprises a therapeutic compound delivery lumen configured to deliver a therapeutic compound to the treatment zone during the clot dissolution treatment.

19. The catheter of claim 18, wherein the thermal energy source and the thermal energy detector are positioned within the therapeutic compound delivery lumen.

20. The catheter of claim 18, wherein the thermal energy source is positioned outside the therapeutic compound delivery lumen, and the thermal energy detector is positioned within the therapeutic compound delivery lumen.

21. The catheter of claim 19, wherein the thermal measurement signal comprises a periodic pulse of increased temperature.

22. The catheter of claim 20, wherein the control circuitry is configured to compare the peak intensity of the thermal measurement signal delivered from the thermal energy source to the peak intensity of the thermal measurement signal received at the thermal energy detector.

23. The catheter of claim 17, wherein the catheter further comprises a cooling fluid lumen configured to flow a cooling fluid proximal to the ultrasonic assembly during the clot dissolution treatment.

24. The catheter of claim 23, wherein the thermal energy source and the thermal energy detector are positioned within the cooling fluid lumen.

25. The catheter of claim 24, wherein the thermal measurement signal comprises a periodic pulse of increased temperature.

26. The catheter of claim 25, wherein the control circuitry is configured to compare the peak intensity of the thermal measurement signal delivered from the thermal energy source to the peak intensity of the thermal measurement signal received at the thermal energy detector.

27. An apparatus comprising:

a catheter having an upstream region, a downstream region and a treatment zone partially extending into both the upstream region and the downstream region;

an ultrasonic assembly positioned within the treatment zone, the ultrasonic assembly comprising at least one ultrasound radiating member configured to perform a clot dissolution treatment;

a thermal energy detector positioned in the treatment zone, the thermal energy detector configured to make a plurality of thermal energy measurements during the clot dissolution treatment;

electrical circuitry for measuring thermal dilution in the treatment zone during the clot dissolution treatment; and

a user interface for displaying a signal corresponding to a blood flow rate, whereby the clot dissolution treatment may be adjusted.

28. A method comprising:

positioning a catheter having an ultrasound radiating member proximal to an obstruction in a patient'"'"'s vasculature;

performing an obstruction dissolution treatment by applying a therapeutic compound and ultrasonic energy to the obstruction such that the obstruction is at least partially dissolved;

sensing an at least partial reestablishment of blood flow past the partially dissolved obstruction; and

adjusting the obstruction dissolution treatment in response to the at least partial reestablishment of blood flow.

29. The method of claim 28, wherein the at least partial reestablishment of blood flow is sensed by taking a plurality of thermal measurements in the patient'"'"'s vasculature.

30. The method of claim 29, wherein the plurality of thermal measurements comprise introducing a thermal measurement signal into the patient'"'"'s vasculature at an upstream location, receiving a the thermal measurement signal from the patient'"'"'s vasculature at a downstream location, and comparing the introduced thermal measurement signal with the received thermal measurement signal.

31. The method of claim 30, wherein the introduced thermal measurement signal is a periodic increased temperature pulse.

32. The method of claim 30, wherein the introduced thermal measurement signal is an oscillating thermal signal.

33. The method of claim 32, further comprising measuring the phase difference between the introduced thermal measurement signal and the received thermal measurement signal.

34. The method of claim 28, wherein the at least partial reestablishment of blood flow is sensed by taking a plurality of acoustic measurements in the patient'"'"'s vasculature.

35. The method of claim 28, wherein the at least partial reestablishment of blood flow is sensed by taking a plurality of optical measurements in the patient'"'"'s vasculature.

36. A method comprising:

positioning a catheter with an ultrasound radiating member at a treatment site in a patient'"'"'s vasculature, wherein a blockage is located at the treatment site;

applying ultrasonic energy at the treatment site;

making a plurality of thermal energy measurements; and

determining if the ultrasound radiating member is positioned within the blockage or blood based on an evaluation of the thermal energy measurements.

37. The method of claim 36, further comprising delivering a therapeutic compound to the treatment site.