LEADLESS PACING SYSTEM INCLUDING SENSING EXTENSION

• US 20160015322A1
• Filed: 04/23/2015
• Published: 01/21/2016
• Est. Priority Date: 07/17/2014
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Anderson, Thomas A., Sheldon, Todd J., Bonner, Matthew D., Neafus, Noelle C.
• Granted Patent: US 10,674,928 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/362 Heart stimulators heart defibrillators A61N1/39
• 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 pacing system includes a leadless pacing device and a sensing extension extending from a housing of the leadless pacing device. The sensing extension includes one or more electrodes with which the leadless pacing device may sense electrical cardiac activity. The one or more electrodes of the sensing extension may be carried by a self-supporting body that is configured to passively position the one or more electrodes proximate or within a chamber of the heart other than the chamber in which the LPD is implanted.

Claims

1. A system comprising:

a leadless pacing device comprising;

a stimulation module configured to generate pacing pulses;

a sensing module;

a processing module;

a housing comprising a conductive portion, wherein the housing is configured to be implanted within a chamber of a heart of a patient and encloses the stimulation module, the sensing module, and the processing module; and

a first electrode electrically coupled to the sensing module and the stimulation module; and

a sensing extension extending from the housing and comprising;

a self-supporting body extending from the housing and comprising a curved proximal portion; and

a second electrode carried by the self-supporting body and electrically connected to the sensing module and the stimulation module via the conductive portion of the housing,

wherein the processing module is configured to control the sensing module to sense electrical cardiac activity via the second electrode.

2. The system of claim 1, further comprising an eyelet at a proximal end of the sensing extension.

3. The system of claim 2, wherein the second electrode defines a blind hole configured to receive the eyelet.

4. The system of claim 1, wherein the conductive portion of the housing is electrically connected to the sensing module, the sensing extension comprising an electrical conductor electrically connecting the second electrode to the conductive portion of the housing.

5. The system of claim 1, wherein the self-supporting body has a stiffness of about 1.6 Newtons-square meter.

6. The system of claim 1, wherein the self-supporting body has a stiffness of about 0.8×

10<sup>−

6</sup> Newtons-square meter (N-m²) to about 4.8×

10<sup>−

6</sup> N-m².

7. The system of claim 6, wherein the self-supporting body further comprises:

an electrically insulative sleeve; and

a coiled conductor within the electrically insulative sheath, the coiled conductor being electrically connected to the second electrode and coiled around the stiffness member.

8. The system of claim 1, wherein a stiffness of the self-supporting body is substantially the same along a length of the self-supporting body.

9. The system of claim 1, wherein a stiffness of the self-supporting body varies along a length of the self-supporting body.

10. The system of claim 1, wherein the sensing extension is configured to remain in the chamber of the heart when the leadless pacing device is implanted in the chamber of the heart.

11. The system of claim 10, wherein the chamber comprises a right ventricle, and wherein the sensing extension is configured to extend from the leadless pacing device towards the right atrium when the leadless pacing device is implanted in an apex of the right ventricle.

12. The system of claim 1, wherein the sensing extension is configured such that the second electrode is located outside a chamber of the heart in which the leadless pacing device resides when the leadless pacing device is implanted in the chamber of the heart.

13. The system of claim 12, wherein the sensing extension is configured such that the second electrode is located in the right atrium of the heart when the leadless pacing device resides in the right ventricle.

14. The system of claim 1, wherein the conductive portion comprises a first conductive portion, the housing further comprising a second conductive portion electrically isolated from the first conductive portion, wherein the first electrode is defined by the second conductive portion.

15. The system of claim 1, wherein the leadless pacing device further comprises a battery and the housing comprises a battery case, and wherein the battery case includes the conductive portion.

16. The system of claim 1, wherein the conductive portion of the housing is substantially completely electrically insulated.

17. The system of claim 1, further comprising an electrically insulative layer over the conductive portion of the housing, wherein the electrically insulative layer exposes a section of the conductive portion of the housing, the section defining a third electrode electrically common with the second electrode.

18. The system of claim 1, wherein the self-supporting body is devoid of any fixation elements.

19. The system of claim 1, wherein the proximal portion of the self-supporting body defines one of a C-shape, an L-shape, or a pigtail shape.

20. A system comprising:

a leadless pacing device comprising;

a stimulation module configured to generate pacing pulses;

a sensing module;

a processing module;

a housing comprising a conductive portion, wherein the housing is configured to be implanted within a chamber of a heart of a patient and encloses the stimulation module, the sensing module, and the processing module, and wherein the conductive portion is electrically connected to the sensing module; and

a first electrode electrically coupled to the sensing module and the stimulation module; and

a sensing extension extending from the housing and comprising;

a self-supporting body mechanically connected to the housing and comprising a conductor electrically connected to the conductive portion of the housing;

a second electrode carried by the self-supporting body and electrically connected to the conductor; and

an eyelet at a proximal end of the sensing extension.

21. The system of claim 20, wherein the self-supporting body comprises a curved proximal portion.

22. The system of claim 20, wherein the second electrode defines a blind hole configured to receive the eyelet.

23. The system of claim 20, wherein the self-supporting body has a stiffness of about 0.8×

10<sup>−

6</sup> Newtons-square meter (N-m²) to about 4.8×

10<sup>−

6</sup> N-m².

24. The system of claim 23, wherein the self-supporting body further comprises:

an electrically insulative sleeve; and

a coiled conductor within the electrically insulative sheath, the coiled conductor being electrically connected to the second electrode and coiled around the stiffness member.

25. The system of claim 20, wherein the sensing extension is configured to remain in the chamber of the heart when the leadless pacing device is implanted in the chamber of the heart.

26. The system of claim 25, wherein the chamber comprises a right ventricle, and wherein the sensing extension is configured to extend from the leadless pacing device towards the right atrium when the leadless pacing device is implanted in an apex of the right ventricle.

27. The system of claim 20, wherein the sensing extension is configured such that the second electrode is located outside a chamber of the heart in which the leadless pacing device resides when the leadless pacing device is implanted in the chamber of the heart.

28. The system of claim 25, wherein the sensing extension is configured such that the second electrode is located in the right atrium of the heart when the leadless pacing device resides in the right ventricle.

29. The system of claim 20, wherein the self-supporting body is devoid of any fixation elements.

30. A method comprising:

controlling, by a processor, a stimulation module of a leadless pacing device to deliver a pacing pulse to a patient, the leadless pacing device comprising;

the stimulation module;

a sensing module;

the processor;

a housing comprising a conductive portion, wherein the housing is configured to be implanted within a chamber of a heart of a patient and encloses the stimulation module, the sensing module, and the processor; and

a first electrode electrically coupled to the sensing module and the stimulation module; and

controlling, by the processor, the sensing module of the leadless pacing device to sense electrical cardiac activity via the first electrode and a second electrode of a sensing extension that extends from the housing, the sensing extension further comprising;

a self-supporting body extending from the housing and comprising a curved proximal portion; and

the second electrode carried by the self-supporting body and electrically connected to the sensing module and the stimulation module via the conductive portion of the housing.

31. The method of claim 30, further comprising detecting, by the processor, atrial activity based on the sensed electrical cardiac activity, the atrial activity comprising a far-field P-wave.