Leadless Pacemaker with Multiple Electrodes

• US 20130324825A1
• Filed: 06/05/2013
• Published: 12/05/2013
• Est. Priority Date: 06/05/2012
• Status: Abandoned Application

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Ostroff, Alan, Jacobson, Peter M.
• Application Number:
  US13/910,896
• Publication Number:
  US 20130324825A1
• Time in Patent Office: Days
• US Class Current: 600/374
• CPC Class Codes: A61B 5/283 Invasive
• CPC Class Codes: A61B 5/6839 Anchoring means, e.g. barbs
• CPC Class Codes: A61N 1/0573 chacterised by means penetrating the heart tissue, e.g. helix needle or hook
• CPC Class Codes: A61N 1/362 Heart stimulators heart defibrillators A61N1/39
• CPC Class Codes: A61N 1/365 controlled by a physiological parameter, e.g. heart potential evoked response A61N1/371
• CPC Class Codes: A61N 1/3706 Pacemaker parameters stimulation threshold A61N1/371
• CPC Class Codes: A61N 1/371 Capture, i.e. successful stimulation
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula

Abstract

A leadless pacemaker for pacing a heart of a human is provided, which can include any number of features. In some embodiments, the pacemaker can include a hermetic housing, a first electrode configured to fix the pacemaker to the heart, a second electrode exterior to the hermetic housing, a pulse generator disposed in the hermetic housing and configured to generate electrical pulses, the pulse generator being electrically connectable to the first and second electrodes, and a controller disposed in the hermetic housing and operatively connected to the pulse generator and a switching circuit to control the delivery of the electrical pulses between the first electrode or the second electrode and the metallic housing to stimulate the heart. In some embodiments, the pacemaker can include three electrodes, and can pace the heart with a first pair of electrodes and sense the heart with a second pair of electrodes.

Claims

1. A leadless pacemaker for pacing a heart of a human comprising:

a metallic hermetic housing;

a first electrode comprising a fixation device exterior to the hermetic housing and configured to affix the pacemaker to the heart;

a second electrode exterior to the hermetic housing and supported by an insulating header on or near the hermetic housing;

a pulse generator disposed in the hermetic housing and configured to generate electrical pulses, the pulse generator being electrically connectable to the first and second electrodes through two feedthroughs passing through the hermetic housing; and

a controller disposed in the hermetic housing and operatively connected to the pulse generator and a switching circuit to control the delivery of the electrical pulses between the first electrode or the second electrode and the metallic housing to stimulate the heart.

2. The leadless pacemaker of claim 1 wherein the fixation device is a helical screw.

3. The leadless pacemaker of claim 1 wherein the second electrode has a surface area of less than 10 mm².

4. The leadless pacemaker of claim 1 wherein the controller is further configured to control the switching circuit to sense electrical activity from the heart between the first electrode and the metallic housing.

5. The leadless pacemaker of claim 1 wherein the controller is further configured to control the switching circuit to sense electrical activity from the heart between the second electrode and the metallic housing.

6. The leadless pacemaker of claim 1 wherein the controller is further configured to control the switching circuit to sense electrical activity from the heart between the first and second electrodes.

7. The leadless pacemaker of claim 1 wherein the controller is further configured to control the switching circuit to sense evoked response between the first electrode and the metallic housing.

8. The leadless pacemaker of claim 1 wherein the controller is further configured to control the switching circuit to sense evoked response between the second electrode and the metallic housing.

9. The leadless pacemaker of claim 1 wherein the controller is further configured to control the switching circuit to sense evoked response between the first and second electrodes.

10. The leadless pacemaker of claim 1 wherein the first electrode is coated with IROX or TiN.

11. The leadless pacemaker of claim 1 wherein the insulated header is at least 2 mm thick.

12. A leadless pacemaker configured to pace a heart of a human, comprising:

a hermetic housing adapted to be affixed to the heart;

a first electrode exterior to the hermetic housing;

a second electrode exterior to the hermetic housing;

a pulse generator disposed in the hermetic housing and configured to generate electrical pulses, the pulse generator being electrically connectable to the first and second electrodes; and

a controller disposed in the hermetic housing and operatively connected to the pulse generator and a switching circuit to control the first electrode as a stimulation electrode and not a sensing electrode and to drive the second electrode as a sensing electrode and not a stimulation electrode.

13. The leadless pacemaker of claim 12 wherein the first electrode comprises a header electrode supported by an insulating header on or near the hermetic housing and the second electrode comprises a fixation device adapted to affix the hermetic housing to the heart.

14. The leadless pacemaker of claim 12 wherein the first electrode comprises a fixation device adapted to affix the hermetic housing to the heart and the second electrode comprises a header electrode supported by an insulating header on or near the hermetic housing.

15. The leadless pacemaker of claim 12 wherein the first electrode is configured to pace the heart.

16. The leadless pacemaker of claim 15 wherein the second electrode is configured for evoked response sensing of the heart.

17. The leadless pacemaker of claim 16 wherein the hermetic housing comprises a return electrode configured to both pace the heart and sense the heart.

18. A leadless pacemaker, comprising:

a hermetic housing comprising a first electrode;

a fixation device comprising a second electrode, the fixation device being exterior to the hermetic housing and configured to affix the pacemaker to the heart;

a third electrode exterior to the hermetic housing and supported by an insulating header on or near the hermetic housing;

a pulse generator disposed in the hermetic housing and configured to generate electrical pulses, the pulse generator being electrically connectable to the first, second, and third electrodes; and

a controller disposed in the hermetic housing and operatively connected to the pulse generator and a switching circuit to use a first pair of electrodes chosen from the first, second, and third electrodes for pacing of the heart, and to use a second pair of electrodes chosen from the first, second, and third electrodes for evoked response sensing of the heart.

19. The leadless pacemaker of claim 18 wherein the first and second electrodes are used for pacing, and the first and third electrodes are used for sensing.

20. The leadless pacemaker of claim 18 wherein the first and second electrodes are used for pacing, and the second and third electrodes are used for sensing.

21. The leadless pacemaker of claim 18 wherein the first and third electrodes are used for pacing, and the first and second electrodes are used for sensing.

22. The leadless pacemaker of claim 18 wherein the first and third electrodes are used for pacing, and the second and third electrodes are used for sensing.

23. A method of treating a heart, comprising:

affixing a leadless pacemaker to an interior wall of a heart;

pacing the heart with a first electrode and a second electrode of the leadless pacemaker; and

sensing the heart with a second electrode and a third electrode of the leadless pacemaker.

24. The method of claim 23 wherein the first electrode comprises a fixation device, the second electrode comprises a header electrode supported by an insulating header on or near a hermetic housing of the leadless pacemaker, and the third electrode comprises the hermetic housing.