Use of a separate device in managing the pace pulse energy of a cardiac pacemaker

• US 10,434,314 B2
• Filed: 10/25/2017
• Issued: 10/08/2019
• Est. Priority Date: 10/27/2016
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Ludwig, Jacob M., Maile, Keith R.
• Primary Examiner(s): Porter, Allen
• Application Number:
  US15/793,199
• Publication Number:
  US 20180117336A1
• Time in Patent Office: 713 Days
• CPC Class Codes: A61N 1/36146 specified by the stimulation parameters
• CPC Class Codes: A61N 1/3622 comprising two or more electrodes co-operating with different heart regions
• CPC Class Codes: A61N 1/36521 the parameter being derived from measurement of an electrical impedance
• CPC Class Codes: A61N 1/371 Capture, i.e. successful stimulation
• CPC Class Codes: A61N 1/37288 Communication to several implantable medical devices within one patient
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 1/3956 Implantable devices for applying electric shocks to the heart, e.g. for cardioversion

Abstract

A medical system may include a first medical device such as a leadless cardiac pacemaker (LCP) that is configured to pace a patient'"'"'s heart and a second medical device that is configured to have a capture threshold capability. The second medical device may monitor the patient'"'"'s heart to ascertain whether the pacing pulses from the first medical device are capturing the heart, and to send the first medical device instructions to alter an energy level of subsequent pacing pulses.

Claims

1. A leadless cardiac pacemaker (LCP) configured to pace a patient'"'"'s heart, the LCP disposable within a chamber of the patient'"'"'s heart, the LCP comprising:

a housing;

a pair of pacing electrodes secured relative to the housing;

a controller disposed within the housing and operably coupled to the pair of pacing electrodes, the controller configured to generate and deliver a plurality of pacing pulses via the pair of pacing electrodes, wherein each of the plurality of pacing pulses has a controllable pacing energy level; and

a communications module operably coupled to the controller, the communications module configured to receive a pacing energy signal from a second implantable medical device that results from an automatic capture threshold capability of the second implantable medical device, wherein the pacing energy signal causes the controller of the LCP to change the pacing energy level of one or more subsequent pacing pulses of the plurality of pacing pulses.

2. The LCP of claim 1, wherein the controller is free of a capture verification capability.

3. The LCP of claim 1, wherein the controller is configured to change the pacing energy level by adjusting a voltage of one or more of the subsequent pacing pulses.

4. The LCP of claim 1, wherein the controller is configured to change the pacing energy level by adjusting a pulse width of one or more of the subsequent pacing pulses.

5. The LCP of claim 4, wherein the pacing energy signal causes the controller to incrementally increase the pacing energy level of two or more subsequent pacing pulses of the plurality of pacing pulses until the communications module receives another signal from the second implantable medical device indicating that the pacing pulses are now capturing the patient'"'"'s heart.

6. The LCP of claim 1, wherein the pacing energy signal causes the controller to increase the pacing energy level of one or more subsequent pacing pulses of the plurality of pacing pulses.

7. The LCP of claim 1, wherein the pacing energy signal causes the controller to decrease the pacing energy level of one or more subsequent pacing pulses of the plurality of pacing pulses.

8. The LCP of claim 7, wherein the pacing energy signal causes the controller to incrementally decrease the pacing energy level of two or more subsequent pacing pulses of the plurality of pacing pulses until the communications module receives another signal from the second implantable medical device indicating that the pacing pulses are no longer capturing the patient'"'"'s heart.

9. The LCP of claim 1, wherein the controller is configured to include a safety mode in which the controller generates and delivers pacing pulses at a predetermined energy level when the communications module is not able to receive signals from the second implantable medical device.

10. The LCP of claim 1, wherein the controller is configured to determine when and whether to generate and deliver a pacing pulse based upon electrical cardiac signals received by the LCP.

11. A medical system for sensing and regulating cardiac activity of a patient, the medical system comprising:

a leadless cardiac pacemaker (LCP) configured to pace a patient'"'"'s heart, the LCP disposable within a chamber of the patient'"'"'s heart, the LCP comprising;

a housing;

a pair of pacing electrodes secured relative to the housing;

a controller disposed within the housing and operably coupled to the pair of pacing electrodes, the controller configured to generate and deliver a plurality of pacing pulses to the heart via the pair of pacing electrodes, wherein each of the plurality of pacing pulses has a controllable pacing energy level;

a communications module operably coupled to the controller;

a second medical device having an automatic capture threshold capability, wherein the automatic capture threshold capability is configured to determine whether pacing pulses generated and delivered by the LCP are capturing the heart, and to selectively generate a pacing energy signal to control the pacing energy level of one or more subsequent pacing pulses generated and delivered by the LCP;

wherein the second medical device is implantable; and

the communications module of the LCP is configured to receive the pacing energy signal from the second medical device, and in response, the controller of the LCP is configured to change the pacing energy level of one or more subsequent pacing pulses of the plurality of pacing pulses.

12. The medical system of claim 11, wherein the second medical device comprises an implantable cardioverter configured to generate and deliver shocks to the patient'"'"'s heart.

13. The medical system of claim 11, wherein the pacing energy signal causes the controller of the LCP to increase the pacing energy level of one or more subsequent pacing pulses of the plurality of pacing pulses.

14. The medical system of claim 13, wherein the pacing energy signal causes the controller of the LCP to incrementally increase the pacing energy level of two or more subsequent pacing pulses of the plurality of pacing pulses until the communications module receives another signal from the second medical device indicating that the pacing pulses are now capturing the patient'"'"'s heart.

15. The medical system of claim 11, wherein the pacing energy signal causes the controller of the LCP to decrease the pacing energy level of one or more subsequent pacing pulses of the plurality of pacing pulses.

16. The medical system of claim 15, wherein the pacing energy signal causes the controller of the LCP to incrementally decrease the pacing energy level of two or more subsequent pacing pulses of the plurality of pacing pulses until the communications module receives another signal from the second medical device indicating that the pacing pulses are no longer capturing the patient'"'"'s heart.

17. A method of sensing and regulating cardiac activity of a patient'"'"'s heart using a leadless cardiac pacemaker (LCP) that is configured to sense cardiac electrical activity and generate and deliver pacing pulses to a patient'"'"'s heart accordingly, and an implantable second medical device that is configured to sense cardiac electrical activity and generate and deliver shocks to cardiac tissue, the method comprising:

monitoring cardiac electrical activity with the LCP;

generating and delivering a pacing pulse with the LCP at a pacing pulse energy level;

monitoring cardiac activity with the implantable second medical device;

determining with the implantable second medical device whether the pacing pulse delivered by the LCP captured the patient'"'"'s heart; and

if the pacing pulse did not capture the patient'"'"'s heart, the implantable second medical device instructing the LCP to increase the pacing pulse energy level for a subsequent pacing pulse.

18. The method of claim 17, further comprising, if the pacing pulse did capture the patient'"'"'s heart:

the implantable second medical device instructing the LCP to decrease the pacing pulse energy level for a subsequent pacing pulse;

the LCP generating and delivering the subsequent pacing pulse at the decreased pacing pulse energy level;

the implantable second medical device monitoring cardiac activity to determine if the subsequent pacing pulse captured the patient'"'"'s heart.

19. The method of claim 18, further comprising, if the pacing pulse did capture the patient'"'"'s heart:

The implantable second medical device continuing to instruct the LCP to decrease the pacing pulse energy level for a subsequent pacing pulse and determining if the subsequent pacing pulse captured the patient'"'"'s heart until the implantable second medical device indicates that the subsequent pacing pulse did not capture the patient'"'"'s heart.