High-resolution mapping of tissue with pacing

• US 10,166,062 B2
• Filed: 06/10/2016
• Issued: 01/01/2019
• Est. Priority Date: 11/19/2014
• Status: Active Grant

• Current Assignee: EPIX Therapeutics, Inc. (Medtronic Plc)
• Original Assignee: EPIX Therapeutics, Inc. (Medtronic Plc)
• Inventors: Panescu, Dorin
• Primary Examiner(s): Kim, Eunhwa
• Application Number:
  US15/179,861
• Publication Number:
  US 20160278842A1
• Time in Patent Office: 935 Days
• CPC Class Codes: A61B 18/12 by passing a current through the tissue to be heated, e.g. high-frequency current
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 18/14 Probes or electrodes 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 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00666 using a threshold value
• CPC Class Codes: A61B 5/283 Invasive
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61N 1/0565 Electrode heads
• CPC Class Codes: A61N 1/36514 controlled by a physiological quantity other than heart potential, e.g. blood pressure controlled by two or more physical parameters A61N1/36585
• CPC Class Codes: A61N 1/371 Capture, i.e. successful stimulation

Abstract

According to some embodiments, a method of confirming successful ablation of targeted cardiac tissue of a subject using a high-resolution mapping electrode comprises pacing said cardiac tissue at a predetermined pacing level to increase the heart rate of the subject from a baseline level to an elevated level, the predetermined pacing level being greater than a pre-ablation pacing threshold level but lower than a post-ablation pacing threshold level, delivering ablative energy to the ablation electrode, detecting the heart rate of the subject, wherein the heart rate detected by the high-resolution mapping electrode is at the elevated level before the post-ablation pacing threshold level is achieved, and wherein the heart rate detected by the high-resolution mapping electrode drops below the elevated level once ablation achieves its therapeutic goal or target, and terminating the delivery of ablative energy to the ablation electrode after the heart rate drops below the elevated level.

Claims

1. A system for delivering ablative energy to targeted cardiac tissue of a subject and for confirming successful ablation of said targeted cardiac tissue, comprising:

a catheter comprising a high-resolution electrode along a distal end of the catheter;

an energy delivery module comprising a processor, the energy delivery module being configured to operatively couple to the catheter, wherein the energy delivery module is configured to energize the high-resolution electrode to deliver the ablative energy to the targeted cardiac tissue adjacent the high-resolution electrode; and

a pacemaker, wherein the pacemaker is integral to the energy delivery module;

wherein the system is configured to detect a signal relating to a localized heart rate at the high-resolution electrode via the high-resolution electrode;

wherein the energy delivery module is configured to selectively pace cardiac the targeted tissue in order to attain capture of the heart of the subject;

wherein the system is configured, via a predetermined pacing signal provided to the catheter by the pacemaker, to increase the heart rate of the subject from a baseline level to an elevated level, the predetermined pacing signal comprising a pacing level greater than a pre-ablation pacing threshold level;

wherein the processor is configured to terminate the energization of the high-resolution electrode after loss of capture of the heart of the subject; and

wherein the high-resolution electrode comprises a distal portion and a proximal portion, the distal and proximal portions of the high-resolution electrode being operatively coupled to each other using at least one filtering element and wherein the distal and proximal portions function as a single electrode when the ablative energy is delivered by the high-resolution electrode to the targeted cardiac tissue, wherein the filtering element comprises a capacitor configured to energize both the proximal and distal portions when the ablative energy is delivered by the high-resolution electrode to the targeted cardiac tissue, wherein the predetermined pacing signal is configured to be delivered via the distal and proximal portions of the high-resolution electrode.

2. The system of claim 1,

wherein the energy delivery module is configured to deliver radiofrequency (RF) energy to the high-resolution electrode;

wherein the energy delivery module comprises a radiofrequency (RF) generator;

wherein the pacing level of the predetermined pacing signal is 5 to 20 milliamps (mA);

wherein the system is configured to increase the heart rate of the subject upon pacing the targeted cardiac tissue at the predetermined pacing level of 100 to 200 beats per minute (bpm); and

wherein the energy delivery module comprises at least one filter, the at least one filter being configured to isolate the signal relating to the localized heart rate signal.

3. The system of claim 1, wherein the catheter further comprises at least one additional mapping electrode.

4. The system of claim 1, wherein the pacing level of the predetermined pacing signal is 5 to 20 milliamps (mA).

5. The system of claim 1, wherein the pacing level of the predetermined pacing signal is 10 to 15 milliamps (mA).

6. The system of claim 1, wherein the system is configured to increase the heart rate of the subject upon pacing the targeted cardiac tissue at the predetermined pacing level of 100 to 200 beats per minute (bpm).

7. The system of claim 1, wherein the pre-ablation pacing threshold level is 0.1 to 3 milliamps (mA).

8. The system of claim 1, wherein the processor is configured to terminate the delivery of the ablative energy by the high-resolution electrode to the targeted cardiac tissue as soon as the heart rate of the subject drops below the elevated level or after loss of capture of the heart of the subject.

9. The system of claim 1, wherein the processor is configured to terminate the delivery of the ablative energy by the high-resolution electrode to the targeted cardiac tissue following a pre-determined time period after the heart rate of the subject drops below the elevated level or after loss of capture of the heart of the subject.

10. The system of claim 9, wherein the pre-determined time period comprises 0.5 to 10 seconds.

11. A system for delivering ablative energy to targeted cardiac tissue of a subject and for confirming successful ablation of said targeted cardiac tissue, comprising:

a catheter comprising a high-resolution electrode along a distal end of the catheter; and

an energy delivery module comprising a processor, the energy delivery module being configured to operatively couple to the catheter, wherein the energy delivery module is configured to energize the high-resolution electrode to deliver the ablative energy to the targeted cardiac tissue adjacent the high-resolution electrode;

wherein the system is configured to detect a signal relating to a localized heart rate at the high-resolution electrode using the high-resolution electrode;

wherein the energy delivery module is configured to couple to a pacemaker for selectively pacing cardiac tissue in order to selectively increase a heart rate of the subject;

wherein the system is configured, via a predetermined pacing signal provided to the catheter by the pacemaker, to increase the heart rate of the subject from a baseline level to an elevated level, the predetermined pacing signal comprising a pacing level greater than a pre-ablation pacing threshold level and less than a post-ablation pacing threshold level;

wherein the system is configured to maintain a heart rate of the subject is at the elevated level before the post-ablation pacing threshold level is achieved;

wherein the system is configured such that a heart rate of the subject falls below the elevated level once the high-resolution electrode has ablated adjacent tissue to a target therapeutic level;

wherein the processor is configured to terminate the delivery of the ablative energy by the high-resolution electrode to the targeted cardiac tissue after the subject'"'"'s heart rate drops below the elevated level;

wherein the high-resolution electrode comprises a distal portion and a proximal portion, the distal and proximal portions of the high-resolution electrode being operatively coupled to each other using at least one filtering element, wherein the filtering element comprises a capacitor;

wherein the system is configured to energize both the proximal and distal portions when ablative energy is delivered to the high-resolution electrode such that the proximal and distal portions function as a single electrode; and

wherein the predetermined pacing signal is configured to be delivered via the distal and proximal portions of the high-resolution electrode.

12. The system of claim 11, wherein the catheter further comprises at least one additional mapping electrode.

13. A method of confirming successful ablation of targeted cardiac tissue of a subject using a high-resolution electrode, comprising:

pacing said targeted cardiac tissue at a predetermined pacing level to increase a heart rate of the subject from a baseline level to an elevated level, the predetermined pacing level being greater than a pre-ablation pacing threshold level and less than a post-ablation pacing threshold level;

detecting a signal relating to a localized heart rate at the high-resolution electrode via the high-resolution electrode;

wherein the high-resolution electrode comprises a distal portion and a proximal portion, the distal and proximal portions of the high-resolution electrode being operatively coupled to each other using at least one filtering element, wherein the at least one filtering element comprises a capacitor; and

wherein pacing the targeted cardiac tissue comprises providing a pacing signal delivered via the distal and proximal portions of the high-resolution electrode,

delivering ablative energy to the high-resolution electrode while pacing;

wherein both the proximal portion and the distal portion of the high-resolution electrode are configured to be energized when the ablative energy is delivered by the high-resolution electrode to the targeted cardiac tissue, wherein the distal and proximal portions function as a single electrode when the ablative energy is delivered by the high-resolution electrode to the targeted cardiac tissue;

obtaining mapping data using the distal and proximal portions of the high-resolution electrode;

detecting a drop in the heart rate of the subject below the elevated level once the high-resolution electrode has successfully ablated the targeted cardiac tissue of the subject, wherein the predetermined pacing level exceeds the post-ablation pacing threshold level;

terminating the delivery of the ablative energy by the high-resolution electrode to the targeted cardiac tissue after the heart rate of the subject drops below the elevated level;

wherein pacing the targeted cardiac tissue is performed via an energy delivery module that is configured to energize to the high-resolution electrode, wherein the energy delivery module comprises a radiofrequency (RF) generator; and

wherein pacing the targeted cardiac tissue comprises operatively coupling a pacemaker to the energy delivery module that is configured to deliver the ablative energy by the high-resolution electrode to the targeted cardiac tissue.

14. The method of claim 13,

wherein the predetermined pacing level is 5 to 20 milliamps (mA);

wherein the elevated level of the heart rate upon pacing the targeted cardiac tissue at the predetermined pacing level is 100 to 200 beats per minute (bpm);

wherein terminating the delivery of the ablative energy by the high-resolution electrode to the targeted cardiac tissue occurs following a predetermined time period after the heart rate of the subject drops below the elevated level; and

wherein the predetermined time period comprises 0.5 to 10 seconds.

15. The method of claim 13, wherein terminating the delivery of the ablative energy by the high-resolution electrode to the targeted cardiac tissue occurs immediately after the heart rate of the subject drops below the elevated level.

16. The method of claim 13, wherein terminating the delivery of the ablative energy by the high-resolution electrode to the targeted cardiac tissue occurs following a predetermined time period after the heart rate of the subject drops below the elevated level.

17. The method of claim 16, wherein the predetermined time period comprises 0.5 to 10 seconds.

18. The method of claim 13, wherein the pacemaker is integral within the energy delivery module.