Single chamber leadless intra-cardiac medical device with dual-chamber functionality

• US 8,798,740 B2
• Filed: 01/17/2012
• Issued: 08/05/2014
• Est. Priority Date: 11/03/2011
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Inventors: Samade, Richard, Karst, Edward, Bornzin, Gene A., Poore, John W., Somogyi, Zoltan, Theret, Didier, Dalal, Nirav
• Primary Examiner(s): Patel, Niketa
• Assistant Examiner(s): Hankins, Lindsey G
• Application Number:
  US13/352,048
• Publication Number:
  US 20130116738A1
• Time in Patent Office: 931 Days
• Field of Search: 607/4, 607/9, 607/30, 607/33, 607126-130
• US Class Current: 607/4
• CPC Class Codes: A61N 1/0573 chacterised by means penetrating the heart tissue, e.g. helix needle or hook
• CPC Class Codes: A61N 1/3684 for stimulating the heart at multiple sites of the ventricle or the atrium
• CPC Class Codes: A61N 1/36843 Bi-ventricular stimulation
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

A leadless intra-cardiac medical device (LIMD) includes a housing configured to be implanted entirely within a single local chamber of the heart.

Claims

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

a housing configured to be implanted entirely within a single local chamber of the heart, the local chamber having local wall tissue that constitutes part of a conduction network of the local chamber;

the housing including a stabilizer arm having a distal end that extends outward from the housing, the stabilizer arm having a pusher cup located at the distal end, the pusher cup configure to receive a pusher tool, the stabilizer arm having a core structure that is torque and compression resistant such that when the pusher tool is rotated or moved longitudinally, the stabilizer arm conveys rotation and longitudinal force from the pusher tool to the housing;

a base on the housing, the base configured to be secured to tissue of interest that separates the local chamber from an adjacent chamber, the adjacent chamber having distal wall tissue, with respect to the local chamber, that constitutes part of a conduction network of the adjacent chamber;

a first electrode provided on the base and extending outward such that, when the device is implanted in the local chamber, the first electrode is configured to engage wall tissue at a distal activation site within the conduction network of the adjacent chamber;

an extension arm provided on the housing and extending outward from the housing;

a second electrode provided on the extension arm and located such that, when the extension arm is positioned in the local chamber, the second electrode is configured to engage wall tissue at a local activation site within the conduction network of the local chamber; and

a controller within the housing to cause stimulus pulses to be delivered, in a synchronous manner, through the first and second electrodes to the distal and local activation sites, respectively, such that stimulus pulses delivered at the distal activation site are timed to cause contraction of the adjacent chamber in a predetermined relation to contraction of the local chamber.

2. The device of claim 1, wherein the stabilizer arm is joined to a top end of the housing, the extension arm having the second electrode located on a distal end thereof to extend into and engage the local wall tissue in an appendage area of the local chamber, the stabilizer arm having a distal end that extends to and engages an opposed stabilization area of the local chamber.

3. The device of claim 1, wherein the tissue of interest represents a portion of the triangle of Koch, the second electrode is configured to engage the distal activation site which is in the ventricular vestibule, the first electrode is configured to engage the local activation site which is in the triangle of Koch, the first and second electrodes delivering stimulus pulses to the triangle of Koch and the ventricular vestibule to initiate activation in a right atrium and right ventricle, respectively.

4. The device of claim 1, wherein the controller is configured to control delivery, from the first and second electrodes, of the stimulus pulses to a right atrium and a right ventricle, while the housing is entirely located in one of the right atrium and right ventricle.

5. The device of claim 1, wherein at least one of the first and second electrodes represent surface bump type electrodes that passively engage the wall tissue.

6. The device of claim 1, wherein the base includes mounting elements to secure the first and second electrodes to the housing in an electrically isolated manner.

7. The device of claim 1, wherein the second electrode has different first and second cross-sections at proximal and distal ends thereof.

8. The device of claim 1, wherein the second electrode includes a conductive wire that has different first and second iso-diameters at the proximal and distal ends thereof.

9. The device of claim 1, wherein the base includes spikes to facilitate active fixation to the septum.

10. A leadless intra-cardiac medical device (LIMD), comprising:

a housing configured to be implanted entirely within a single local chamber of the heart, the local chamber having local wall tissue that constitutes part of a conduction network of the local chamber;

a base on the housing, the base configured to be secured to tissue of interest that separates the local chamber from an adjacent chamber, the adjacent chamber having distal wall tissue, with respect to the local chamber, that constitutes part of a conduction network of the adjacent chamber;

a first electrode provided on the base and extending outward such that, when the device is implanted in the local chamber, the first electrode is configured to engage wall tissue at a distal activation site within the conduction network of the adjacent chamber;

an extension arm provided on the housing and extending outward from the housing;

the housing including a stabilizer arm, the extension arm and stabilizer arm pivotally joined to a hinge assembly located at a top end of the housing;

a second electrode provided on the extension arm and located such that, when the extension arm is positioned in the local chamber, the second electrode is configured to engage wall tissue at a local activation site within the conduction network of the local chamber; and

a controller within the housing to cause stimulus pulses to be delivered, in a synchronous manner, through the first and second electrodes to the distal and local activation sites, respectively, such that stimulus pulses delivered at the distal activation site are timed to cause contraction of the adjacent chamber in a predetermined relation to contraction of the local chamber.

11. The device of claim 10, wherein the tissue of interest represents a portion of the triangle of Koch, the second electrode is configured to engage the distal activation site which is in the ventricular vestibule, the first electrode is configured to engage the local activation site which is in the triangle of Koch, the first and second electrodes delivering stimulus pulses to the triangle of Koch and the ventricular vestibule to initiate activation in a right atrium and right ventricle, respectively.

12. The device of claim 10, wherein the controller is configured to control delivery, from the first and second electrodes, of the stimulus pulses to a right atrium and a right ventricle, while the housing is entirely located in one of the right atrium and right ventricle.

13. The device of claim 10, wherein at least one of the first and second electrodes represent surface bump type electrodes that passively engage the wall tissue.

14. The device of claim 10, wherein the base includes mounting elements to secure the first and second electrodes to the housing in an electrically isolated manner.

15. The device of claim 10, wherein the second electrode has different first and second cross-sections at proximal and distal ends thereof.

16. The device of claim 10, wherein the second electrode includes a conductive wire that has different first and second iso-diameters at the proximal and distal ends thereof.

17. The device of claim 10, wherein the base includes spikes to facilitate active fixation to the septum.

18. A leadless intra-cardiac medical device (LIMD), comprising:

a housing configured to be implanted entirely within a single local chamber of the heart, the local chamber having local wall tissue that constitutes part of a conduction network of the local chamber;

a base on the housing, the base configured to be secured to tissue of interest that separates the local chamber from an adjacent chamber, the adjacent chamber having distal wall tissue, with respect to the local chamber, that constitutes part of a conduction network of the adjacent chamber;

a first electrode provided on the base and extending outward such that, when the device is implanted in the local chamber, the first electrode is configured to engage wall tissue at a distal activation site within the conduction network of the adjacent chamber;

an extension arm provided on the housing and extending outward from the housing;

the housing including a stabilizer arm, the extension arm and stabilizer arm securely joined to a top end of the housing, the extension arm and stabilizer arm being biased to flare outward away from one another when in a deployed position such that distal ends of the stabilization and extension arms engage the local chamber in opposed areas remote from the base of the housing;

a second electrode provided on the extension arm and located such that, when the extension arm is positioned in the local chamber, the second electrode is configured to engage wall tissue at a local activation site within the conduction network of the local chamber; and

a controller within the housing to cause stimulus pulses to be delivered, in a synchronous manner, through the first and second electrodes to the distal and local activation sites, respectively, such that stimulus pulses delivered at the distal activation site are timed to cause contraction of the adjacent chamber in a predetermined relation to contraction of the local chamber.

19. The device of claim 18, wherein the tissue of interest represents a portion of the triangle of Koch, the second electrode is configured to engage the distal activation site which is in the ventricular vestibule, the first electrode is configured to engage the local activation site which is in the triangle of Koch, the first and second electrodes delivering stimulus pulses to the triangle of Koch and the ventricular vestibule to initiate activation in a right atrium and right ventricle, respectively.

20. The device of claim 18, wherein the controller is configured to control delivery, from the first and second electrodes, of the stimulus pulses to a right atrium and a right ventricle, while the housing is entirely located in one of the right atrium and right ventricle.

21. The device of claim 18, wherein at least one of the first and second electrodes represent surface bump type electrodes that passively engage the wall tissue.

22. The device of claim 18, wherein the base includes mounting elements to secure the first and second electrodes to the housing in an electrically isolated manner.

23. The device of claim 18, wherein the second electrode has different first and second cross-sections at proximal and distal ends thereof.

24. The device of claim 18, wherein the second electrode includes a conductive wire that has different first and second iso-diameters at the proximal and distal ends thereof.

25. The device of claim 18, wherein the base includes spikes to facilitate active fixation to the septum.

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

a housing configured to be implanted entirely within a single local chamber of the heart, the local chamber having local wall tissue that constitutes part of a conduction network of the local chamber;

a base on the housing, the base configured to be secured to tissue of interest that separates the local chamber from an adjacent chamber, the adjacent chamber having distal wall tissue, with respect to the local chamber, that constitutes part of a conduction network of the adjacent chamber;

a first electrode provided on the base and extending outward such that, when the device is implanted in the local chamber, the first electrode is configured to engage wall tissue at a distal activation site within the conduction network of the adjacent chamber;

an extension arm provided on the housing and extending outward from the housing;

the housing being elongated along a longitudinal axis, the housing being joined to the extension arm such that the extension arm moves between an introduction contracted position substantially in-line with the longitudinal axis of the housing and a deployed flared position that projects at an acute angle from the longitudinal axis of the housing to position the first electrode against the local wall tissue;

a second electrode provided on the extension arm and located such that, when the extension arm is positioned in the local chamber, the second electrode is configured to engage wall tissue at a local activation site within the conduction network of the local chamber; and

a controller within the housing to cause stimulus pulses to be delivered, in a synchronous manner, through the first and second electrodes to the distal and local activation sites, respectively, such that stimulus pulses delivered at the distal activation site are timed to cause contraction of the adjacent chamber in a predetermined relation to contraction of the local chamber.

27. The device of claim 26, wherein the tissue of interest represents a portion of the triangle of Koch, the second electrode is configured to engage the distal activation site which is in the ventricular vestibule, the first electrode is configured to engage the local activation site which is in the triangle of Koch, the first and second electrodes delivering stimulus pulses to the triangle of Koch and the ventricular vestibule to initiate activation in a right atrium and right ventricle, respectively.

28. The device of claim 26, wherein the controller is configured to control delivery, from the first and second electrodes, of the stimulus pulses to a right atrium and a right ventricle, while the housing is entirely located in one of the right atrium and right ventricle.

29. The device of claim 26, wherein at least one of the first and second electrodes represent surface bump type electrodes that passively engage the wall tissue.

30. The device of claim 26, wherein the base includes mounting elements to secure the first and second electrodes to the housing in an electrically isolated manner.

31. The device of claim 26, wherein the second electrode has different first and second cross-sections at proximal and distal ends thereof.

32. The device of claim 26, wherein the base includes spikes to facilitate active fixation to the septum.