Electrogram-based ablation control

• US 9,918,788 B2
• Filed: 10/31/2012
• Issued: 03/20/2018
• Est. Priority Date: 10/31/2012
• Status: Active Grant

• Current Assignee: St. Jude Medical (Abbott Laboratories Incorporated)
• Original Assignee: St. Jude Medical (Abbott Laboratories Incorporated)
• Inventors: Paul, Saurav, Byrd, Charles Bryan, Holte, James, Kuehn, Mick, Tegg, Troy, Shai, Yitzhak, Pacheco, Robert, Pasvogel, Matt
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Morales, Jon Eric C
• Application Number:
  US13/665,287
• Publication Number:
  US 20140121659A1
• Time in Patent Office: 1,966 Days
• Field of Search: 606 41, 606 34
• 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 2018/00351 Heart
• CPC Class Codes: A61B 2018/00648 using more than one sensed parameter
• CPC Class Codes: A61B 2018/00666 using a threshold value
• CPC Class Codes: A61B 2018/00839 Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2034/301 for introducing or steering flexible instruments inserted into the body, e.g. catheters or endoscopes
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis

Abstract

Methods, devices, and systems for predicting, diagnosing, and preventing adverse events during an ablation procedure are described. A method for providing ablation energy includes receiving a first signal based on biological activity of a tissue of a patient. The method further includes analyzing the first signal to yield a first data set, establishing a threshold parameter according to the first data set, and providing ablation energy for the ablation of a biological site.

Claims

1. A device for controlling the provision of ablation energy, the device comprising:

a memory configured to store a threshold parameter indicative of previously-measured electrical activity of a tissue of a patient, wherein the threshold is determined from a characterization of an electrogram; and

an electronic control unit (ECU) configured to;

receive an electrogram respective of the patient detected from inside the patient;

analyze said electrogram to yield a data set comprising frequency content of said electrogram;

compare at least a portion of said data set to said threshold parameter to detect an adverse event; and

modify the provision of ablation energy based, at least in part, on a comparison of said data set to said threshold parameter.

2. The device of claim 1, wherein said data set comprises one or more amplitudes of said electrogram at one or more frequencies.

3. The device of claim 2, wherein said threshold parameter comprises one or more amplitudes at one or more frequencies.

4. The device of claim 1, wherein said ECU is configured to analyze said electrogram using a time-series analysis.

5. The device of claim 1, wherein said ECU is configured to analyze said electrogram using a frequency-domain analysis.

6. The device of claim 1, wherein said ECU is configured to analyze said electrogram using a multi-dimensional analysis.

7. The device of claim 1, wherein said second electrogram comprises an intracardiac electrogram.

8. The device of claim 1, wherein said ECU is configured to modify the provision of ablation energy by interrupting the provision of ablation energy.

9. The device of claim 1, wherein said electrogram is a first electrogram and said data set is a first data set, further wherein said ECU is further configured to receive a second electrogram respective of the patient and detected from inside the patient, said second electrogram indicative of electrical activity of the tissue, analyze said second electrogram to yield a second data set comprising frequency content of the electrical activity, and establish said threshold parameter according to said second data set, further wherein said second electrogram is earlier in time than said first data set electrogram.

10. A system for performing an ablation procedure, the system comprising:

an ablation generator configured to provide ablation energy to a medical device including one or more electrodes; and

an electronic control unit (ECU) configured to;

receive a signal detected with at least one of said one or more electrodes based on the biological activity of a patient and detected from inside the patient;

analyze said signal to yield a data set comprising frequency content of said signal;

compare at least a portion of said data set to a threshold parameter to detect an adverse event, said threshold parameter indicative of electrical activity of a tissue of the patient, wherein the threshold is determined from a characterization of an electrogram; and

provide a command for said ablation generator to modify the provision of ablation energy based, at least in part, on a comparison of said data set to said threshold parameter.

11. The system of claim 10, wherein said signal comprises a unipolar electrogram detected using one of said one or more electrodes disposed on a distal tip of said medical device.

12. The system of claim 10, wherein said signal comprises a multi-polar electrogram detected using one of said one or more electrodes disposed on a distal tip of said medical device and at least another of said one or more electrodes.

13. The system of claim 10, further comprising an output mechanism configured to output an alert when said threshold parameter is exceeded.

14. A method for providing ablation energy, comprising:

receiving a first electrogram respective of a patient and detected from within the patient;

analyzing said first electrogram to yield a first data set comprising frequency content of said first electrogram;

establishing a threshold parameter according to said first data set, wherein the threshold is determined from a characterization of the first electrogram;

providing ablation energy for the ablation of a biological site;

receiving a second electrogram respective of the patient and detected from within the patient after receiving said first electrogram;

analyzing said second signal to yield a second data set comprising frequency content of said second electrogram;

comparing at least a portion of said second data set to said threshold parameter to predict the likelihood of an adverse event; and

modifying a parameter of provided ablation energy according to said comparison.

15. The method of claim 14, wherein said threshold parameter comprises an amplitude and a frequency.

16. The method of claim 14, wherein said analyzing steps comprise a time-series analysis.

17. The method of claim 14, wherein said analyzing steps comprise a frequency-domain analysis.

18. The method of claim 14, wherein said analyzing steps comprise a multi-dimensional analysis.

19. The method of claim 14, wherein said step of receiving said first electrogram is performed before said step of providing ablation energy.

20. The method of claim 19, wherein said step of receiving said second electrogram is performed substantially simultaneously with said step of providing ablation energy.