Ablation devices, systems and method for measuring cooling effect of fluid flow

• US 9,320,565 B2
• Filed: 12/31/2008
• Issued: 04/26/2016
• Est. Priority Date: 12/31/2008
• Status: Active Grant

• Current Assignee: St. Jude Medical (Abbott Laboratories Incorporated)
• Original Assignee: St. Jude Medical (Abbott Laboratories Incorporated)
• Inventors: Schneider, Clinton W., Gerhart, John P.
• Primary Examiner(s): GILBERT, ANDREW M
• Application Number:
  US12/347,558
• Publication Number:
  US 20100168738A1
• Time in Patent Office: 2,673 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 18/1206 Generators therefor
• 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 2018/00011 with fluids
• CPC Class Codes: A61B 2018/00642 with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/00648 using more than one sensed parameter
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension

Abstract

Disclosed herein are various catheter and catheter systems that are useful in ablating tissue that is also subject to surface perfusion, for example blood flow across and/or through tissue. A representative embodiment of a catheter useful with the present invention includes an anemometer located on an exterior surface of the distal portion of the catheter. The anemometer is thermally isolated from the distal tip to permit the anemometer to measure the cooling effect of surface perfusion. The ablation catheter may include thermal insulation to insulate the anemometer from the distal tip. Alternatively, and/or in addition, the anemometer may be positioned proximally of the distal tip. The catheter may include one or more temperature sensors thermally coupled to the distal tip to measure the temperature of the distal tip. The distal tip may include one or more spiral grooves, or one or more holes. It is contemplated that the anemometer may be positioned within any such spiral groove or hole using a thermal insulation material, such as a non-conductive adhesive. The catheter may optionally include a contact sensor on the distal portion to assess a degree of contact between the ablation catheter and tissue being treated. Various ablation systems and methods are described herein that utilize catheters as described above.

Claims

1. An ablation catheter for ablating tissue in need of treatment, wherein the tissue is subjected to surface perfusion, comprising:

a proximal portion and a distal portion, said distal portion having a distal tip;

at least one ablation electrode on the distal tip; and

an anemometer located on an exterior surface of the distal portion, said anemometer being thermally isolated from the distal tip to permit the anemometer to measure a cooling effect of surface perfusion, and wherein the anemometer comprises a bridge circuit having at least one hot wire located on the surface of the distal portion and at least one resistor of the bridge circuit located within the ablation catheter.

2. The ablation catheter of claim 1 wherein the anemometer is located on the distal tip, the ablation catheter further comprising thermal insulation to insulate the anemometer from the distal tip.

3. The ablation catheter of claim 1 wherein the anemometer is located proximal of the distal tip.

4. The ablation catheter of claim 1 wherein the distal tip includes one or more spiral grooves, and the anemometer is positioned within a spiral groove.

5. The ablation catheter of claim 4 further comprising thermal insulation between the anemometer and the spiral groove.

6. The ablation catheter of claim 5 wherein the spiral groove is less than about 0.5 mm wide.

7. The ablation catheter of claim 1 wherein the distal tip has one or more holes of less than about 0.5 mm in diameter, and wherein the anemometer is positioned within one or more holes.

8. The ablation catheter of claim 7 further comprising thermal insulation between the anemometer and the distal tip.

9. The ablation catheter of claim 1 wherein the anemometer is located proximally of the distal tip and comprises a film circuit having the bridge circuit with at least one temperature responsive resistor encased with a thermally-conductive, electrically insulative material.

10. The ablation catheter of claim 1 further comprising a contact sensor on the distal portion that assesses a degree of contact between the ablation catheter and tissue being treated.

11. An ablation system for ablating tissue in need of treatment, comprising:

an ablation catheter having;

a proximal portion and a distal portion, said distal portion having a distal tip;

at least one ablation electrode on the distal tip; and

an anemometer located on an exterior surface of the distal portion, said anemometer being thermally isolated from the distal tip to permit the anemometer to measure a cooling effect of surface perfusion and wherein the anemometer comprises a bridge circuit having at least one hot wire located on the surface of the distal portion and at least one resistor of the bridge circuit located within the ablation catheter;

a contact assessment device that assesses a degree of contact between the ablation catheter and tissue being treated;

a power source coupled to the at least one ablation electrode, said power source being programmable to deliver at least one programmable level of power;

a clock to measure a time period during which ablative power is delivered to the tissue being treated;

a power monitoring device to monitor the amount of ablation power that is delivered by the ablation catheter; and

a lesion analysis processor for estimating lesion formation as a function of at least;

i) an output of the anemometer that provides information on surface perfusion;

ii) an output of the contact assessment device;

iii) an output of the clock; and

iv) an output of the power monitoring device.

12. The ablation system of claim 11 wherein the contact assessment device is a force sensor located on the distal portion of the ablation catheter that assesses a degree of contact between the ablation catheter and tissue being treated.

13. The ablation system of claim 11 wherein the contact assessment device comprises a temperature sensor thermally coupled to the distal tip, which temperature sensor monitors for a change in temperature indicative of contact with the tissue to be treated.

14. The ablation system of claim 11 wherein the contact assessment device comprises a temperature sensor thermally coupled to the distal tip, the ablation electrode, and the power source, wherein the ablation system applies a low level of power sufficient to cause a measurable increase in a temperature of any tissue in contact with the ablation electrode, but insufficient to ablate the tissue, and the temperature sensor monitors for a change in temperature indicative of tissue being in contact with the ablation electrode.

15. The ablation system of claim 11 further comprising a controller coupled to the power source and to the lesion analysis processor, said controller regulating the power source based on information provided by the lesion analysis processor.

16. The ablation system of claim 15 further comprising at least one tissue temperature measurement device coupled to the controller such that if the temperature of the tissue being ablated exceeds a maximum desirable temperature, the controller will deactivate the power source.

17. The ablation system of claim 16 wherein the at least one tissue temperature measurement device comprises a thermistor.

18. The ablation system of claim 16 wherein the at least one tissue temperature measurement device comprises a second anemometer located on an exterior surface of the distal portion, said second anemometer being located in a position such that it can measure a temperature of the tissue being treated.

19. The ablation system of claim 15 further comprising:

an electrophysiology electrode located on the distal portion to measure electrical activity associated with tissue to be treated;

wherein the controller is coupled to the electrophysiology electrode and monitors for a change in an output of the electrophysiology electrode that is indicative of the tissue having been sufficiently ablated to create a conduction block.

20. The ablation system of claim 15 wherein the controller estimates a size of the lesion being formed during treatment and deactivates the power source when the estimated lesion size exceeds a target size.

21. The ablation system of claim 11 wherein the lesion analysis processor further estimates lesion formation as a function of:

v) tissue thickness; and

vi) internal perfusion.

22. The ablation system of claim 11 wherein the distal tip includes one or more grooves, and the anemometer is positioned within one of the grooves.

23. The ablation system of claim 11 wherein the distal tip includes one or more holes less than about 0.5 mm in diameter, and the anemometer is positioned within one of the holes.

24. A method of ablating tissue comprising:

placing an ablation catheter in contact with tissue to be ablated, said catheter having;

a proximal portion and a distal portion, said distal portion having a distal tip;

an ablation electrode located in the distal tip coupled to an ablation energy source for delivering ablation energy to the tissue; and

and

an anemometer located on an exterior surface of the distal portion, said anemometer is positioned to permit the anemometer to measure a cooling effect of surface perfusion and wherein the anemometer comprises a bridge circuit having at least one hot wire located on the surface of the distal portion and at least one resistor of the bridge circuit located within the ablation catheter;

activating the ablation energy source to deliver ablation energy to the tissue to be ablated;

using an output of the anemometer to estimate lesion formation; and

deactivating the ablation energy source when an estimated lesion formation reaches a desired level.

25. The method of claim 24 further comprising:

assessing a degree of contact between the catheter and tissue being treated; and

measuring the amount of ablation energy that is delivered to the tissue being treated as a function of time;

wherein using an output of the anemometer to estimate lesion formation comprises;

using a processor to estimate lesion formation as a function of at least;

i) an output of the anemometer that indicates an amount of surface perfusion;

ii) the assessed degree of contact; and

iii) the measured amount of ablation energy that is delivered over a treatment period of time.

26. The method of claim 24 further comprising monitoring a temperature of the tissue being treated and deactivating the ablation energy source if the monitored tissue temperature exceeds a maximum desired tissue temperature.

27. The method of claim 24 further comprising using the anemometer to estimate a velocity of a fluid passing over the anemometer.