DISTAL BALLOON IMPEDANCE AND TEMPERATURE RECORDING TO MONITOR PULMONARY VEIN ABLATION AND OCCLUSION

• US 20150157382A1
• Filed: 12/04/2014
• Published: 06/11/2015
• Est. Priority Date: 12/06/2013
• Status: Active Grant

• Current Assignee: Medtronic CryoCath LP (Medtronic Plc)
• Original Assignee: Medtronic CryoCath LP (Medtronic Plc)
• Inventors: CONDIE, Catherine R., AVITALL, Boaz
• Granted Patent: US 9,993,279 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00404 Blood vessels other than those in or around the heart
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00684 using lookup tables
• CPC Class Codes: A61B 2018/00821 measured by a thermocouple
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2018/0268 with restriction of flow

Abstract

A cryoablation method, system, and device that allows for real-time and accurate assessment and monitoring of PV occlusion and lesion formation without the need for expensive imaging systems and without patient exposure to radiation. The system includes a cryoballoon catheter with a cryoballoon, a distal electrode, a proximal electrode, and a temperature sensor. Impedance measurements recorded by the electrodes may be used to predict ice formation, quality of pulmonary vein occlusion, and lesion formation.

Claims

1. A method of assessing lesion quality in pulmonary vein ostium tissue, the method comprising:

recording a first set of impedance measurements from an electrode on a balloon catheter having a treatment element at a distal portion;

recording a second set of impedance measurements from the electrode;

determining a first impedance slope using the first set of impedance measurements and determining a second impedance slope using the second set of impedance measurements;

comparing the first slope to a first reference slope and comparing the second slope to a second reference slope;

determining whether the balloon catheter is creating a permanent lesion in the pulmonary vein ostium based on the comparison of the first slope to the first reference slope and the second slope to the second reference slope; and

repositioning the treatment element when it is determined that the balloon catheter is not creating a permanent lesion in the pulmonary vein ostium tissue.

2. The method of claim 1, further comprising:

recording a set of temperature measurements from a thermocouple on the balloon catheter; and

comparing the set of temperature measurements to the first slope and second slope of impedance measurements and comparing the set of temperature measurements to a reference temperature.

3. The method of claim 1, further comprising:

recording a set of temperature measurements from the electrode; and

comparing the set of temperature measurements to the first slope and second slope of impedance measurements and comparing the set of temperature measurements to a reference temperature.

4. The method of claim 1, wherein the electrode is a first electrode, the method further comprising:

recording a first set of impedance measurements from a second electrode on the balloon catheter;

recording a second set of impedance measurements from the second electrode;

determining a third impedance slope using the first set of impedance measurements from the second electrode and determining a fourth impedance slope using the second set of impedance measurements from the second electrode;

comparing the third slope and the fourth slope;

comparing the first slope and the third slope;

comparing the second slope and the fourth slope;

determining, based on the comparison between the first, second, third, and fourth slopes, whether the balloon catheter is creating a permanent lesion in the pulmonary vein ostium tissue; and

repositioning the treatment element when it is determined that the balloon catheter is not creating a permanent lesion in the pulmonary vein tissue.

5. The method of claim 2, wherein the electrode is located distal to the treatment element.

6. The method of claim 4, wherein the first electrode is located distal to the treatment element and the second electrode is located distal to the first electrode.

7. The method of claim 6, wherein the first electrode is located distal to and adjacent to the treatment element.

8. The method of claim 4, wherein the first electrode is located distal to the treatment element and the second electrode is located proximal to the treatment element.

9. The method of claim 8, wherein the first electrode is located distal to and adjacent to the treatment element.

10. The method of claim 1, wherein the first slope and second slope at least partially define an impedance curve, and the impedance curve represents impedance measured by the electrode when the pulmonary vein is completely occluded.

11. The method of claim 10, wherein the comparison between the first slope and the second slope indicates a thickness of ice formed when the treatment element is activated.

12. The method of claim 11, wherein determining whether the balloon catheter is creating a permanent lesion in the pulmonary vein ostium tissue includes correlating the ice thickness to the creation of a permanent lesion by the balloon catheter.

13. The method of claim 12, wherein a determination of a permanent lesion is made when the ice thickness is at least 3 mm.

14. The method of claim 12, wherein a determination of a permanent lesion is made when an impedance measured by the electrode is at least 2000 Ω

.

15. The method of claim 14, wherein a determination of occlusion permanent lesion is made when an impedance measured by the electrode is at least 2000Ω

within 120±

30 sec.

16. The method of claim 2, wherein the electrode is located distal to and adjacent to the treatment element and the thermocouple is proximate the electrode.

17. A method of assessing pulmonary vein ostium lesion quality, the method comprising:

positioning a balloon catheter proximate a pulmonary vein ostium, the balloon catheter including a longitudinal axis and a balloon;

reducing the temperature of the balloon to a temperature sufficient to ablate the pulmonary vein ostium;

recording a first set of impedance measurements from each of a plurality of electrodes radially disposed about the longitudinal axis immediately distal to the balloon;

recording a second set of impedance measurements from each of the plurality of electrodes;

determining a first impedance slope using the first set of impedance measurements from each of the plurality of electrodes and determining a second impedance slope using the second set of impedance measurements from each of the plurality of electrodes;

comparing the first impedance slope and the second impedance slope for each of the plurality of electrodes to generate an impedance curve for each of the plurality of electrodes;

comparing the impedance curves of the plurality of electrodes to each other;

determining, based on the comparison between the impedance curves, at least one of;

whether the balloon catheter is creating a permanent lesion in the pulmonary vein ostium;

whether the balloon catheter is not occluding the pulmonary vein;

whether the balloon catheter is partially occluding the pulmonary vein; and

whether the balloon catheter is completely occluding the pulmonary vein;

determining, when the comparison indicates that the balloon catheter is partially occluding the pulmonary vein, a radial position of an area of the treatment element that is not in contact with tissue; and

repositioning the treatment element until a determination of at least one of complete occlusion and the creation of a permanent lesion is made.

18. A method of determining cryoablation lesion quality, the method comprising:

positioning a cryoballoon coupled to an ablation catheter in contact with a pulmonary vein ostium, the ablation catheter further including;

a first electrode immediately distal to the cryoballoon;

a second electrode distal to the first electrode; and

at least one thermocouple proximate the first electrode, the first and second electrodes being within the pulmonary vein;

initiating a flow of coolant within the cryoballoon to cool the cryoballoon to a temperature sufficient to ablate the pulmonary vein ostium;

continuously recording impedance measurements from the first electrode;

continuously recording impedance measurements from the second electrode;

continuously recording temperature measurements from the thermocouple; and

determining that a circumferential ablation lesion will be formed around the pulmonary vein ostium when the first electrode measures an impedance of at least 2000Ω and

the thermocouple measures a temperature of −

37.8±

3.3°

C. within 120±

30 sec from the onset of the flow of coolant within the cryoballoon.

19. A system for cryoablating tissue, the system comprising:

a cryoablation device, the device including;

a balloon coupled to a distal portion of the device;

a first electrode immediately distal to the balloon;

a second electrode a distance from the first electrode; and

at least one thermocouple proximate the first electrode;

a source of coolant in fluid communication with the balloon; and

a console including a processor, the processor programmed to;

receive impedance measurements recorded by the first and second electrodes;

receive temperature measurements recorded by the thermocouple; and

determine whether the balloon is creating a permanent lesion in a pulmonary vein ostium, the determination based on at least one of the impedance measurements from the first electrode, impedance measurements from the second electrode, and temperature measurements from the at least one thermocouple.

20. The system of claim 19, wherein the processor is further programmed to:

calculate a thickness of ice formed between the balloon and the pulmonary vein ostium; and

determine that the balloon will create a substantially circumferential lesion about the pulmonary vein ostium when the processor determines that the ice thickness is at least 3 mm.

21. The system of claim 19, wherein the second electrode is proximal to the balloon, the processor further programmed to:

compare impedance measured by the first electrode to impedance measured by the second electrode; and

determine whether the balloon is completely occluding the pulmonary vein based on the comparison between the impedance measured by the first electrode and the impedance measured by the second electrode.