Implantable electrode location selection

• US 9,877,789 B2
• Filed: 06/12/2013
• Issued: 01/30/2018
• Est. Priority Date: 06/12/2013
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Ghosh, Subham
• Primary Examiner(s): Mahmood, Nadia A
• Application Number:
  US13/916,353
• Publication Number:
  US 20140371832A1
• Time in Patent Office: 1,693 Days
• Field of Search: 607129
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 2562/043 in a linear array
• CPC Class Codes: A61B 2562/046 in a matrix array
• CPC Class Codes: A61B 2576/023 for the heart
• CPC Class Codes: A61B 34/10 Computer-aided planning, simulation or modelling of surgical operations
• CPC Class Codes: A61B 5/0044 for the heart
• CPC Class Codes: A61B 5/055 involving electronic [EMR] or nuclear [NMR] magnetic resonance, e.g. magnetic resonance imaging
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/339 Displays specially adapted therefor
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/489 Blood vessels
• CPC Class Codes: A61B 5/6805 Vests
• CPC Class Codes: A61B 5/6823 Trunk, e.g., chest, back, abdomen, hip
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/743 Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots
• CPC Class Codes: A61B 5/7435 Displaying user selection data, e.g. icons in a graphical user interface
• CPC Class Codes: A61B 6/12 Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61B 6/4405 the apparatus being movable or portable, e.g. handheld or mounted on a trolley
• CPC Class Codes: A61B 6/4441 : the rigid structure being a C-arm or U-arm
• CPC Class Codes: A61B 6/463 : characterised by displaying multiple images or images and diagnostic data on one display
• CPC Class Codes: A61B 6/481 : involving the use of contrast agents
• CPC Class Codes: A61B 6/486 : involving generating temporal series of image data
• CPC Class Codes: A61B 6/503 : for diagnosis of the heart
• CPC Class Codes: A61B 6/504 : for diagnosis of blood vessels, e.g. by angiography
• CPC Class Codes: A61N 1/0484 : Garment electrodes worn by the patient
• CPC Class Codes: A61N 1/3627 : for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: A61N 1/368 : comprising more than one electrode co-operating with different heart regions A61N1/3622, A61N1/3627 take precedence
• CPC Class Codes: A61N 1/372 : Arrangements in connection with the implantation of stimulators
• CPC Class Codes: A61N 1/37247 : User interfaces, e.g. input or presentation means
• CPC Class Codes: G16H 30/40 : for processing medical images, e.g. editing

Abstract

Systems, methods, and interfaces are described herein for assisting in noninvasive location selection for an implantable electrode for use in cardiac therapy. Mechanical motion information and surrogate electrical activation times may be used to identify one or more candidate site regions.

Claims

1. A system for assisting in noninvasive location selection for an implantable electrode comprising:

electrode apparatus comprising a plurality of external electrodes configured to be located proximate tissue of a patient;

imaging apparatus configured to image at least a portion of blood vessel anatomy of the patient'"'"'s heart;

a display apparatus comprising a graphical user interface, wherein the graphical user interface is configured to depict the at least a portion of blood vessel anatomy of the patient'"'"'s heart for implantation of an implantable electrode; and

computing apparatus coupled to the electrode apparatus, imaging apparatus, and display apparatus and configured to provide an automated recommendation engine to assist a user in noninvasively selecting a location for the implantable electrode, wherein the computing apparatus is further configured to;

measure mechanical motion of a plurality of implantation site regions of the at least a portion of blood vessel anatomy of the patient'"'"'s heart using the imaging apparatus,

automatically identify one or more identified site regions of the plurality of implantation site regions of the at least a portion of blood vessel anatomy of the patient'"'"'s heart for implantation of the implantable electrode based on the measured mechanical motion, wherein the one or more identified site regions comprise mechanical motion contraction times greater than or equal to a mechanical motion threshold based on the latest mechanical motion contraction time of the plurality of implantation site regions,

noninvasively measure surrogate electrical activation time of the one or more of identified site regions of the patient'"'"'s heart using the plurality of external electrodes of the electrode apparatus, wherein the surrogate electrical activation time for each region of the one or more of identified site regions is non-invasively measured using one or more external electrodes without use of an implantable electrode,

automatically determine one or more candidate site regions of the one or more of identified site regions of the at least a portion of blood vessel anatomy of the patient'"'"'s heart for implantation of the implantable electrode based on the measured electrical activation time of the one or more of identified site regions, wherein the one or more candidate site regions comprise electrical activation times greater than or equal to an electrical activation threshold based on the latest electrical activation time of the one or more of identified site regions, and

identify, on the graphical user interface, the one or more candidate site regions for implantation of the implantable electrode.

2. The system of claim 1, wherein, to measure surrogate electrical activation time of the one or more of identified site regions of the patient'"'"'s heart using the plurality of external electrodes of the electrode apparatus, the computing apparatus is configured to measure surrogate electrical activation time of each region using one or more external electrodes of the plurality of electrodes proximate to the identified site region for which the surrogate electrical activation time is being measured.

3. The system of claim 1, wherein, to measure surrogate electrical activation time of the one or more identified site regions of the patient'"'"'s heart using the plurality of electrodes of the electrode apparatus, the computing apparatus is further configured to:

determine positions of the plurality of external electrodes with respect to the one or more identified site regions of the at least a portion of blood vessel anatomy of the patient'"'"'s heart using the imaging apparatus;

associate one or more external electrodes with each region of the one or more identified site regions of the at least a portion of blood vessel anatomy of the patient'"'"'s heart; and

measure surrogate electrical activation time of each region of the one or more identified site regions of the at least a portion of blood vessel anatomy of the patient'"'"'s heart using the one or more external electrodes associated therewith.

4. The system of claim 1, wherein one or more external electrodes of the plurality of external electrodes are associated with each region of the plurality of implantation site regions, wherein the plurality of external electrodes are configured to be positioned proximate tissue of the patient by a user, wherein the one or more external electrodes associated with each region of the plurality of implantation site regions are configured be positioned proximate an area of the patient associated with the respective region of the plurality of implantation site regions,

wherein, to measure surrogate electrical activation time of the one or more identified site regions of the patient'"'"'s heart using the plurality of electrodes of the electrode apparatus, the computing apparatus is further configured to measure surrogate electrical activation time of each region of the one or more identified site regions of the at least a portion of blood vessel anatomy of the patient'"'"'s heart using the one or more external electrodes associated therewith.

5. The system of claim 1, wherein the mechanical motion threshold is a selected percentage of the latest mechanical motion contraction time of the plurality of implantation site regions and the electrical activation threshold is a selected percentage of the latest electrical activation time of the one or more identified site regions.

6. The system of claim 1, wherein the computing apparatus is further configured to:

determine a scar risk score for each region of the one or more candidate site regions; and

identify, on the graphical user interface, at least one target site region of the one or more candidate site regions based on the scar risk score for implantation of the implantable electrode.

7. The system of claim 6, wherein the scar risk score is based on at least one of peak-to-peak amplitude of measured mechanical motion of the candidate site region, fractionations of the electrical activity of the candidate site region measured using the one or more electrodes used to measure the surrogate electrical activation time therefor, ST segment elevation of the electrical activity of the candidate site region measured using the one or more electrodes used to measure the surrogate electrical activation time therefor, and low peak-to-peak amplitude of the electrical activity of the candidate site region measured using the one or more electrodes used to measure the surrogate electrical activation time therefor.

8. The system of claim 1, wherein the at least a portion of blood vessel anatomy of the patient'"'"'s heart comprises at least a portion of the coronary sinus.

9. The system of claim 1, wherein the plurality of external electrodes comprises surface electrodes positioned in an array configured to be located proximate the skin of the patient.

10. A method for assisting in noninvasive location selection for an implantable electrode using an automated recommendation engine comprising:

measuring mechanical motion of a plurality of implantation site regions of at least a portion of blood vessel anatomy of the patient'"'"'s heart using imaging apparatus;

automatically identifying one or more identified site regions of the plurality of implantation site regions of the at least a portion of blood vessel anatomy of the patient'"'"'s heart for implantation of the implantable electrode based on the measured mechanical motion, wherein the one or more identified site regions comprise mechanical motion contraction times greater than or equal to mechanical motion threshold based on the latest mechanical motion contraction time of the plurality of implantation site regions,

noninvasively measuring surrogate electrical activation time of the one or more identified site regions of the patient'"'"'s heart using a plurality of external electrodes, wherein the surrogate electrical activation time for each region of the one or more identified site regions is noninvasively measured using one or more external electrodes without use of an implantable electrode;

automatically determining one or more candidate site regions of the one or more identified site regions of the at least a portion of blood vessel anatomy of the patient'"'"'s heart for implantation of an implantable electrode based on measured electrical activation time of the one or more identified site regions, wherein the one or more candidate site regions comprise electrical activation times greater than or equal to an electrical activation threshold based on the latest electrical activation time of the one or more identified site regions;

identifying, on a graphical user interface, the one or more candidate site regions for implantation of the implantable electrode; and

navigating at least one implantable electrode to at least one of the identified one or more candidate site regions using the graphical user interface.

11. The method of claim 10, wherein measuring surrogate electrical activation time of the one or more identified site regions of the patient'"'"'s heart using the plurality of external electrodes comprises measuring surrogate electrical activation time of each identified site region using one or more external electrodes proximate thereto.

12. The method of claim 10, wherein measuring surrogate electrical activation time of the one or more identified site regions of the patient'"'"'s heart using the plurality of external electrodes comprises:

determining positions of the plurality of external electrodes with respect to the one or more identified site regions of the at least a portion of blood vessel anatomy of the patient'"'"'s heart using the imaging apparatus;

associating one or more external electrodes with each region of the one or more identified site regions of the at least a portion of blood vessel anatomy of the patient'"'"'s heart; and

measuring surrogate electrical activation time of each region of the one or more identified site regions of the at least a portion of blood vessel anatomy of the patient'"'"'s heart using the one or more external electrodes associated therewith.

13. The method of claim 10, wherein one or more external electrodes of the plurality of external electrodes are associated with each region of the plurality of implantation site regions, wherein measuring surrogate electrical activation time of the one or more identified site regions of the patient'"'"'s heart using the plurality of external electrodes comprises:

positioning the plurality of external electrodes proximate tissue of the patient, wherein the one or more external electrodes associated with each region of the plurality of implantation site regions are positioned proximate an area of the patient associated with the respective region of the plurality of implantation site regions,

wherein, to measure surrogate electrical activation time of the one or more identified site regions of the patient'"'"'s heart using the plurality of electrodes of the electrode apparatus, the computing apparatus is further configured to measure surrogate electrical activation time of each region of the one or more identified site regions of the at least a portion of blood vessel anatomy of the patient'"'"'s heart using the one or more external electrodes associated therewith.

14. The method of claim 10, wherein the mechanical motion threshold is a selected percentage of the latest mechanical motion contraction time of the plurality of implantation site regions and the electrical activation threshold is a selected percentage of the latest electrical activation time of the one or more identified site regions.

15. The method of claim 10, wherein the method further comprises:

determining a scar risk score for each region of the one or more candidate site regions;

identifying, on the graphical user interface, at least one target site region of the one or more candidate site regions based on the scar risk score for implantation of the implantable electrode; and

navigating at least one implantable electrode to the at least one identified target site regions using the graphical user interface.

16. The method of claim 15, wherein the scar risk score is based on at least one of peak-to-peak amplitude of measured mechanical motion of the candidate site region, fractionations of the electrical activity of the candidate site region measured using the one or more electrodes used to measure the surrogate electrical activation time therefor, ST segment elevation of the electrical activity of the candidate site region measured using the one or more electrodes used to measure the surrogate electrical activation time therefor, and low peak-to-peak amplitude of the electrical activity of the candidate site region measured using the one or more electrodes used to measure the surrogate electrical activation time therefor.

17. The method of claim 10, wherein the at least a portion of blood vessel anatomy of the patient'"'"'s heart comprises at least a portion of the coronary sinus.

18. The method of claim 10, wherein the plurality of external electrodes comprises surface electrodes positioned in an array configured to be located proximate the skin of the patient.

19. A system for assisting in noninvasive location selection for an implantable electrode comprising:

electrode apparatus comprising a plurality of external electrodes configured to be located proximate tissue of a patient;

imaging apparatus configured to image at least a portion of blood vessel anatomy of the patient'"'"'s heart;

a display apparatus comprising a graphical user interface, wherein the graphical user interface is configured to depict the at least a portion of blood vessel anatomy of the patient'"'"'s heart for implantation of an implantable electrode; and

computing apparatus coupled to the electrode apparatus, imaging apparatus, and display apparatus and configured to provide an automated recommendation engine to assist a user in noninvasively selecting a location for the implantable electrode, wherein the computing apparatus is further configured to;

measure mechanical motion of a plurality of implantation site regions of the at least a portion of blood vessel anatomy of the patient'"'"'s heart using the imaging apparatus,

automatically identify a plurality of identified site regions of the plurality of implantation site regions of the at least a portion of blood vessel anatomy of the patient'"'"'s heart for implantation of the implantable electrode based on the measured mechanical motion,

noninvasively measure surrogate electrical activation time of the plurality of identified site regions of the patient'"'"'s heart using the plurality of external electrodes of the electrode apparatus, wherein the surrogate electrical activation time for each region of the plurality of identified site regions is noninvasively measured using one or more external electrodes without use of an implantable electrode,

automatically determine one or more candidate site regions of the plurality of identified site regions of the at least a portion of blood vessel anatomy of the patient'"'"'s heart for implantation of the implantable electrode based on the measured electrical activation time of the plurality of identified site regions,

determine a scar risk score for each region of the one or more candidate site regions, and

automatically identify, on the graphical user interface, at least one target site region of the one or more candidate site regions based on the scar risk score for implantation of the implantable electrode.

20. The system of claim 19, wherein, to measure surrogate electrical activation time of the plurality of identified site regions of the patient'"'"'s heart using the plurality of external electrodes of the electrode apparatus, the computing apparatus is configured to measured surrogate electrical activation time of each identified site region using one or more external electrodes proximate thereto.

21. The system of claim 19, wherein, to measure surrogate electrical activation time of the plurality of identified site regions of the patient'"'"'s heart using the plurality of electrodes of the electrode apparatus, the computing apparatus is further configured to:

determine positions of the plurality of external electrodes with respect to the plurality of identified site regions of the at least a portion of blood vessel anatomy of the patient'"'"'s heart using the imaging apparatus;

associate one or more external electrodes with each region of the plurality of identified site regions of the at least a portion of blood vessel anatomy of the patient'"'"'s heart; and

measure surrogate electrical activation time of each region of the plurality of identified site regions of the at least a portion of blood vessel anatomy of the patient'"'"'s heart using the one or more external electrodes associated therewith.

22. The system of claim 19, wherein one or more external electrodes of the plurality of external electrodes are associated with each region of the plurality of implantation site regions, wherein the plurality of external electrodes are configured to be positioned proximate tissue of the patient by a user, wherein the one or more external electrodes associated with each region of the plurality of implantation site regions are configured be positioned proximate an area of the patient associated with the respective region of the plurality of implantation site regions,

wherein, to measure surrogate electrical activation time of the plurality of identified site regions of the patient'"'"'s heart using the plurality of electrodes of the electrode apparatus, the computing apparatus is further configured to measure surrogate electrical activation time of each region of the plurality of identified site regions of the at least a portion of blood vessel anatomy of the patient'"'"'s heart using the one or more external electrodes associated therewith.

23. The system of claim 19, wherein the scar risk score is based on at least one of peak-to-peak amplitude of measured mechanical motion of the candidate site region, fractionations of the electrical activity of the candidate site region measured using the one or more electrodes used to measure the surrogate electrical activation time therefor, ST segment elevation of the electrical activity of the candidate site region measured using the one or more electrodes used to measure the surrogate electrical activation time therefor, and low peak-to-peak amplitude of the electrical activity of the candidate site region measured using the one or more electrodes used to measure the surrogate electrical activation time therefor.

24. The system of claim 19, wherein the one or more identified site regions comprise mechanical motion contraction times greater than or equal to a mechanical motion threshold based on the latest mechanical motion contraction time of the plurality of implantation site regions and wherein the one or more candidate site regions comprise electrical activation times greater than or equal to an electrical activation threshold based on the latest electrical activation time of the plurality of identified site regions.

25. The system of claim 19, wherein the at least a portion of blood vessel anatomy of the patient'"'"'s heart comprises at least a portion of the coronary sinus.

26. The system of claim 19, wherein the plurality of external electrodes comprises surface electrodes positioned in an array configured to be located proximate the skin of the patient.

27. A method for assisting in noninvasive location selection for an implantable electrode using an automated recommendation engine comprising:

measuring mechanical motion of a plurality of implantation site regions of at least a portion of blood vessel anatomy of the patient'"'"'s heart using imaging apparatus;

automatically identifying a plurality of identified site regions of the plurality of implantation site regions of the at least a portion of blood vessel anatomy of the patient'"'"'s heart for implantation of the implantable electrode based on the measured mechanical motion;

noninvasively measuring surrogate electrical activation time of the plurality of identified site regions of the patient'"'"'s heart using a plurality of external electrodes, wherein the surrogate electrical activation time for each region of the plurality of identified site regions is noninvasively measured using one or more external electrodes without use of an implantable electrode;

automatically determining one or more candidate site regions of the plurality of identified site regions of the at least a portion of blood vessel anatomy of the patient'"'"'s heart for implantation of an implantable electrode based on the measured electrical activation time of the plurality of identified site regions;

determining a scar risk score for each region of the one or more candidate site regions;

automatically identifying, on the graphical user interface, at least one target site region of the one or more candidate site regions based on the scar risk score for implantation of the implantable electrode; and

navigating at least one implantable electrode to at least one of the identified one or more target site regions using the graphical user interface.

28. The method of claim 27, wherein measuring surrogate electrical activation time of the plurality of identified site regions of the patient'"'"'s heart using the plurality of external electrodes comprises measuring surrogate electrical activation time of each identified site region using one or more external electrodes proximate thereto.

29. The method of claim 27, wherein measuring surrogate electrical activation time of the plurality of identified site regions of the patient'"'"'s heart using the plurality of external electrodes comprises:

determining positions of the plurality of external electrodes with respect to the plurality of identified site regions of the at least a portion of blood vessel anatomy of the patient'"'"'s heart using the imaging apparatus;

associating one or more external electrodes with each region of the plurality of identified site regions of the at least a portion of blood vessel anatomy of the patient'"'"'s heart; and

measuring surrogate electrical activation time of each region of the plurality of identified site regions of the at least a portion of blood vessel anatomy of the patient'"'"'s heart using the one or more external electrodes associated therewith.

30. The method of claim 27, wherein one or more external electrodes of the plurality of external electrodes are associated with each region of the plurality of implantation site regions, wherein measuring surrogate electrical activation time of the plurality of identified site regions of the patient'"'"'s heart using the plurality of external electrodes comprises:

positioning the plurality of external electrodes proximate tissue of the patient, wherein the one or more external electrodes associated with each region of the plurality of implantation site regions are positioned proximate an area of the patient associated with the respective region of the plurality of implantation site regions, and

measuring surrogate electrical activation time of each region of the plurality of identified site regions of the at least a portion of blood vessel anatomy of the patient'"'"'s heart using the one or more external electrodes associated therewith.

31. The method of claim 27, wherein the plurality of identified site regions comprise mechanical motion contraction times greater than or equal to a mechanical motion threshold based on the latest mechanical motion contraction time of the plurality of implantation site regions and wherein the one or more candidate site regions comprise electrical activation times greater than or equal to an electrical activation threshold based on the latest electrical activation time of the plurality of identified site regions, wherein the mechanical motion threshold is a selected percentage of the latest mechanical motion contraction time of the plurality of implantation site regions and the electrical activation threshold is a selected percentage of the latest electrical activation time of the plurality of identified site regions.

32. The method of claim 27, wherein the scar risk score is based on at least one of peak-to-peak amplitude of measured mechanical motion of the candidate site region, fractionations of the electrical activity of the candidate site region measured using the one or more electrodes used to measure the surrogate electrical activation time therefor, ST segment elevation of the electrical activity of the candidate site region measured using the one or more electrodes used to measure the surrogate electrical activation time therefor, and low peak-to-peak amplitude of the electrical activity of the candidate site region measured using the one or more electrodes used to measure the surrogate electrical activation time therefor.

33. The method of claim 27, wherein the plurality of identified site regions comprise mechanical motion contraction times greater than or equal to a mechanical motion threshold based on the latest mechanical motion contraction time of the plurality of implantation site regions and wherein the one or more candidate site regions comprise electrical activation times greater than or equal to an electrical activation threshold based on the latest electrical activation time of the plurality of identified site regions.

34. The method of claim 27, wherein the at least a portion of blood vessel anatomy of the patient'"'"'s heart comprises at least a portion of the coronary sinus.

35. The method of claim 27, wherein the plurality of external electrodes comprises surface electrodes positioned in an array configured to be located proximate the skin of the patient.

36. A system for assisting in noninvasive location selection for an implantable electrode comprising:

electrode apparatus comprising a plurality of external electrodes configured to be located proximate tissue of a patient;

imaging apparatus configured to image at least a portion of blood vessel anatomy of the patient'"'"'s heart;

a display apparatus comprising a graphical user interface, wherein the graphical user interface is configured to depict the at least a portion of blood vessel anatomy of the patient'"'"'s heart for implantation of an implantable electrode; and

computing apparatus coupled to the electrode apparatus, imaging apparatus, and display apparatus and configured to provide an automated recommendation engine to assist a user in noninvasively selecting a location for the implantable electrode, wherein the computing apparatus is further configured to;

measure mechanical motion of a plurality of implantation site regions of the at least a portion of blood vessel anatomy of the patient'"'"'s heart using the imaging apparatus,

automatically identify a plurality of identified site regions of the plurality of implantation site regions of the at least a portion of blood vessel anatomy of the patient'"'"'s heart for implantation of the implantable electrode based on the measured mechanical motion,

noninvasively measure surrogate electrical activation time of the plurality of identified site regions of the patient'"'"'s heart using the plurality of external electrodes of the electrode apparatus, wherein the surrogate electrical activation time for each region of the plurality of identified site regions is noninvasively measured using one or more external electrodes without use of an implantable electrode, and

automatically determine one or more candidate site regions of the plurality of identified site regions of the at least a portion of blood vessel anatomy of the patient'"'"'s heart for implantation of the implantable electrode based on the measured electrical activation time of the plurality of identified site regions.

37. A method for assisting in noninvasive location selection for an implantable electrode using an automated recommendation engine comprising:

measuring mechanical motion of a plurality of implantation site regions of at least a portion of blood vessel anatomy of the patient'"'"'s heart using imaging apparatus;

automatically identifying a plurality of identified site regions of the plurality of implantation site regions of the at least a portion of blood vessel anatomy of the patient'"'"'s heart for implantation of the implantable electrode based on the measured mechanical motion,

noninvasively measuring surrogate electrical activation time of the plurality of identified site regions of the patient'"'"'s heart using a plurality of external electrodes, wherein the surrogate electrical activation time for each region of the plurality of identified site regions is noninvasively measured using one or more external electrodes without use of an implantable electrode; and

automatically determining one or more candidate site regions of the plurality of identified site regions of the at least a portion of blood vessel anatomy of the patient'"'"'s heart for implantation of an implantable electrode based on the measured surrogate electrical activation time of the plurality of identified site regions.