Leadless intra-cardiac medical device with dual chamber sensing through electrical and/or mechanical sensing

• US 8,996,109 B2
• Filed: 05/31/2012
• Issued: 03/31/2015
• Est. Priority Date: 01/17/2012
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Karst, Edward, Samade, Richard, Bornzin, Gene A., Poore, John W., Somogyi, Zoltan, Theret, Didier
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): MAHMOOD, NADIA AHMAD
• Application Number:
  US13/485,513
• Publication Number:
  US 20130325081A1
• Time in Patent Office: 1,034 Days
• Field of Search: 607/25
• US Class Current: 607/25
• CPC Class Codes: A61B 2560/0468 Built-in electrodes
• CPC Class Codes: A61B 5/1107 Measuring contraction of parts of the body, e.g. organ, muscle apparatus for measuring work or force in general G01L
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/363 Detecting tachycardia or bradycardia
• CPC Class Codes: A61B 5/6869 Heart
• CPC Class Codes: A61B 5/6882 Anchoring means
• CPC Class Codes: A61N 1/36507 controlled by gradient or slope of the heart potential
• 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 1/36578 controlled by mechanical motion of the heart wall, e.g. measured by an accelerometer or microphone
• CPC Class Codes: A61N 1/36592 controlled by the heart rate variability
• 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 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

A leadless intra-cardiac medical device senses cardiac activity from multiple chambers and applies cardiac stimulation to at least one cardiac chamber and/or generates a cardiac diagnostic indication. The leadless device may be implanted in a local cardiac chamber (e.g., the right ventricle) and detect near-field signals from that chamber as well as far-field signals from an adjacent chamber (e.g., the right atrium).

Claims

1. A leadless intra-cardiac medical device, comprising:

a housing configured to be positioned entirely within an intra-cardiac space;

at least one first electrode located at a distal section of the housing;

at least one second electrode; and

a processing circuit located within an interior space of the housing and electrically coupled to the at least one first electrode and the at least one second electrode, wherein the processing circuit is configured to;

determine whether at least one ventricular event occurred based on near-field signals sensed using the at least one first electrode,

determine whether at least one atrial event occurred based on far-field signals sensed using the at least one second electrode; and

generate at least one cardiac stimulation pulse based on the determination of whether the at least one ventricular event occurred and the determination of whether the at least one atrial event occurred.

2. The device of claim 1, wherein:

the determination of whether the at least one ventricular event occurred comprises identifying timing of an R wave; and

the determination of whether the at least one atrial event occurred comprises identifying timing of a P wave based on the identified timing of the R wave.

3. The device of claim 1, wherein the determination of whether the at least one atrial event occurred comprises:

filtering the far-field signals based on a first bandwidth;

filtering the far-field signals based on a second bandwidth, wherein the first bandwidth is narrower than the second bandwidth; and

comparing the filtered far-field signals to identify a P wave.

4. The device of claim 1, wherein:

the determination of whether the at least one ventricular event occurred comprises correlating a morphology derived from the near-field signals with at least one ventricular morphology template; and

the determination of whether the at least one atrial event occurred comprises correlating a morphology derived from the far-field signals with at least one atrial morphology template.

5. The device of claim 1, further comprising at least one electro-mechanical sensor, wherein

the processing circuit is further configured to receive signals from the at least one electro-mechanical sensor;

the determination of whether the at least one ventricular event occurred is further based on a first portion of the signals received from the at least one electro-mechanical sensor; and

the determination of whether the at least one atrial event occurred is further based on a second portion of the signals received from the at least one electro-mechanical sensor.

6. The device of claim 1, wherein:

the at least one first electrode comprises at least one helix electrode; and

the at least one second electrode comprises at least one first ring electrode.

7. The device of claim 6, wherein:

the at least one first electrode further comprises at least one second ring electrode; and

the at least one first ring electrode comprises a plurality of ring electrodes.

8. The device of claim 1, wherein:

the at least one first electrode comprises a first bipolar electrode pair; and

the at least one second electrode comprises a second bipolar electrode pair.

9. The device of claim 1, wherein the housing has a cross-sectional width of less than 6 millimeters.

10. The device of claim 9, wherein the housing has a length of at least 30 millimeters.

11. The device of claim 9, wherein the housing has a length of at least 60 millimeters.

12. The device of claim 1, wherein a surface area of each electrode of the at least one second electrode is greater than 2 square millimeters.

13. The device of claim 1, wherein:

the at least one second electrode comprises a pair of electrodes; and

a distance between the pair of electrodes is at least 15 millimeters.

14. The device of claim 1, wherein:

the at least one second electrode comprises a pair of electrodes; and

at least a portion of an exterior surface of the housing between the pair of electrodes is covered by an electrical insulator.

15. The device of claim 1, further comprising a plurality of insulators for electrically insulating the housing from the at least one first electrode and the at least one second electrode.

16. The device of claim 1, wherein the at least one second electrode is located at a proximal section of the housing.

17. The device of claim 16, wherein the proximal section of the housing has a cross-sectional dimension that is smaller than a cross-sectional dimension of the distal section of the housing.

18. The device of claim 16, wherein:

the housing has a length that is greater than 60 millimeters;

the housing comprises a middle section between the proximal section and the distal section;

the middle section of the housing has a cross-sectional dimension that is smaller than a cross-sectional dimension of the distal section of the housing; and

the cross-sectional dimension of the middle section of the housing is smaller than a cross-sectional dimension of the proximal section of the housing.

19. The device of claim 1, further comprising an elongated structural member that extends from the proximal section of the housing, wherein the elongated structural member comprises the at least one second electrode.

20. The device of claim 19, wherein the elongated structural member has a length of at least 30 millimeters.

21. The device of claim 1, further comprising an elongated mechanical support structure that extends from the proximal section of the housing, wherein the elongated mechanical support structure comprises the at least one second electrode.

22. A leadless intra-cardiac medical device that does not employ electrodes for cardiac sensing, comprising:

a housing adapted to be positioned entirely within an intra-cardiac space;

at least one electro-mechanical sensor located within an interior space of the housing; and

a processing circuit located within the interior space of the housing and electrically coupled to the at least one electro-mechanical sensor, wherein the processing circuit is configured to;

determine, based on signals received from the at least one electro-mechanical sensor, whether at least one ventricular event occurred and whether at least one atrial event occurred; and

generate at least one cardiac stimulation pulse based on the determination of whether the at least one ventricular event occurred and whether the at least one atrial event occurred.

23. The device of claim 22, wherein:

the determination of whether the at least one ventricular event occurred comprises correlating mechanical activity information derived from a first portion of the signals received from the at least one electro-mechanical sensor with a ventricular mechanical activity template; and

the determination of whether the at least one atrial event occurred comprises correlating mechanical activity information derived from a second portion of the signals received from the at least one electro-mechanical sensor with an atrial mechanical activity template.

24. The device of claim 22, wherein:

the determination of whether the at least one ventricular event occurred comprises identifying timing of an R wave; and

the determination of whether the at least one atrial event occurred comprises identifying timing of a P wave based on the identified timing of the R wave.

25. The device of claim 22, wherein the at least one electro-mechanical sensor comprises a plurality of accelerometers configured to measure acceleration in different directions.

26. A leadless intra-cardiac medical device, comprising:

a housing configured to be positioned entirely within an intra-cardiac space;

at least one first electrode located adjacent an exterior surface of the housing;

at least one second electrode located adjacent the exterior surface of the housing; and

a processing circuit located within an interior space of the housing and electrically coupled to the at least one first electrode and the at least one second electrode, wherein the processing circuit is configured to;

sense near-field signals in an atrium using the at least one first electrode;

sense far-field signals in the atrium using the at least one second electrode;

identify atrial events based on the sensed near-field signals;

identify ventricular events based on the sensed far-field signals;

determine timing intervals based on the identified atrial events and the identified ventricular events; and

generate a cardiac diagnostic indication based on the timing intervals.

27. The device of claim 26, wherein the determination of the timing intervals comprises generating a histogram based on the identified atrial events and the identified ventricular events.

28. The device of claim 26, wherein:

the identification of the atrial events comprises;

identifying intrinsic atrial events that were detected as a result of the near-field signal sensing and/or identifying paced atrial events that were delivered upon failing to detect intrinsic atrial events as a result of the near-field signal sensing; and

the identification of the ventricular events comprises, for each of the identified intrinsic and/or paced atrial events, determining based on the far-field signal sensing whether a ventricular event occurred within a defined timing window after the atrial event.

29. The device of claim 28, wherein the generation of the cardiac diagnostic indication comprises determining a degree of heart block based on the timing intervals and generating an indication of the degree of heart block.

30. The device of claim 26, wherein:

the at least one second electrode comprises a pair of electrodes; and

a distance between the pair of electrodes is at least 15 millimeters.

31. The device of claim 26, wherein:

the at least one second electrode comprises a pair of electrodes; and

at least a portion of an exterior surface of the housing between the pair of electrodes is covered by an electrical insulator.

32. A cardiac diagnostic method, comprising:

sensing near-field signals in an atrium using at least one first electrode of a leadless intra-cardiac medical device configured to be positioned entirely within an intra-cardiac space;

sensing far-field signals in the atrium using at least one second electrode of a leadless intra-cardiac medical device configured to positioned entirely within an intra-cardiac space;

identifying atrial cardiac events based on the sensed near-field signals;

identifying ventricular events based on the sensed far-field signals;

determining timing intervals based on the identified atrial events and the identified ventricular events; and

generating a cardiac diagnostic indication based on the timing intervals.

33. The method of claim 32, wherein the leadless intra-cardiac medical device is implanted in a heart such that no part of the leadless intra-cardiac medical device is located in a cardiac chamber from which the far-field signals originate.