Method and apparatus for automated control of pacing post-conditioning

• US 8,812,104 B2
• Filed: 09/08/2010
• Issued: 08/19/2014
• Est. Priority Date: 09/23/2009
• Status: Expired due to Fees

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Mokelke, Eric A., Esler, James A.
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): Dinga, Roland
• Application Number:
  US12/877,622
• Publication Number:
  US 20110071584A1
• Time in Patent Office: 1,441 Days
• Field of Search: 607/2, 607/4, 607/9, 607/10
• US Class Current: 607/9
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/3621 for treating or preventing abnormally high heart rate
• CPC Class Codes: A61N 1/3625 External stimulators
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371
• CPC Class Codes: A61N 1/371 Capture, i.e. successful stimulation
• CPC Class Codes: A61N 1/372 Arrangements in connection with the implantation of stimulators
• CPC Class Codes: G16H 20/30 relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

Pacing post-conditioning (PPC) therapy is applied to a patient to minimize ischemic injury associated with MI and/or reperfusion injury associated with a post-MI revascularization procedure. In various embodiments, a PPC therapy is delivered by executing a pacing protocol with pacing parameters determined and dynamically adjusted based on patient-specific factors to ensure efficacy and safety of the patient.

Claims

1. A cardiac pacing system, comprising:

a pacing output circuit to deliver pacing pulses;

a storage device;

one or more pacing post-conditioning (PPC) protocols stored in the storage device, the one or more PPC protocols each specifying a pacing sequence including alternating non-pacing and pacing periods, the non-pacing periods each including a non-pacing duration during which no pacing pulse is timed to be delivered, the pacing periods each including a pacing duration during which a plurality of pacing pulses is timed to be delivered according to a stress augmentation pacing mode adapted to augment myocardial mechanical stress to a level effecting cardioprotection against myocardial injury;

a pacing control circuit coupled to the pacing output circuit and the storage device, the pacing control circuit programmed to execute a current pacing protocol and including;

a parameter input configured to receive one or more protocol generation parameters including at least one or more physiological parameters; and

a protocol generator programmed to generate the current pacing protocol using the one or more PPC protocols and the one or more protocol generation parameters, the current pacing protocol specifying a plurality of pacing parameters, the one or more protocol generation parameters used to calculate one or more pacing parameters of the plurality of pacing parameters.

2. The system of claim 1, wherein the protocol generator is programmed to generate the current pacing protocol by selecting a protocol from the one or more PPC protocols using the one and more protocol generation parameters.

3. The system of claim 2, wherein the protocol generator is programmed to adjust one or more pacing parameters of the plurality of pacing parameters of the selected protocol using the one and more protocol generation parameters.

4. The system of claim 3, wherein the parameter input is configured to receive a heart rate, and the protocol generator is programmed to select the protocol from the one or more PPC protocols using the heart rate and adjust a pacing rate of the plurality of pacing parameters of the selected protocol using the heart rate.

5. The system of claim 2, further comprising a defibrillation output circuit to deliver defibrillation pulses, and wherein the parameter input is further configured to receive one or more parameters indicative of tachyarrhythmia, and the protocol generator is programmed to select the protocol from the one or more PPC protocols using the one or more parameters indicative of tachyarrhythmia.

6. The system of claim 1, wherein the pacing control circuit comprises:

a protocol timer programmed to count a number of cycles each including a non-pacing period followed by a pacing period; and

a protocol terminator programmed to terminate the execution of the current pacing protocol in response to the counted number of cycles reaching a specified number.

7. The system of claim 1, wherein the pacing control circuit comprises:

a protocol timer programmed to time at least one of a total pacing duration and a total therapy duration, the total pacing duration being a sum of the pacing periods in the pacing sequence, the total therapy duration being a sum of the pacing periods and non-pacing periods in the pacing sequence; and

a protocol terminator programmed to terminate the execution of the current pacing protocol in response to at least one of the total pacing duration exceeding a specified minimum pacing time and the total therapy duration exceeding a specified minimum therapy time.

8. The system of claim 1, wherein the pacing control circuit comprises:

a capture verifier programmed to verify whether each of the delivered pacing pulses results in a captured beat being a cardiac depolarization resulting from the each of the delivered pacing pulses;

a capture counter programmed to count a number of the captured beats; and

a protocol terminator programmed to terminate the execution of the current pacing protocol in response to the number of the captured beats detected during the pacing periods in the pacing sequence exceeding a specified minimum number of captured beats.

9. The system of claim 1, comprising

a pacemaker including:

a pacemaker chassis housing at least the pacing output circuit and the pacing control circuit; and

a pacing protocol interface coupled to the pacing control circuit; and

a pacing protocol module external to the pacemaker chassis and configured to be attached to the pacemaker and electrically connected to the pacing protocol interface, the pacing protocol module including the storage device.

10. The system of claim 9, wherein the pacemaker comprises:

a user interface incorporated onto the pacemaker chassis and including a command receiver configured to receive one or more user commands and a parameter receiver configured to receive one or more user parameters;

a sensing circuit to sense one or more physiological signals;

a physiological parameter detector to detect the one or more physiological parameters using the sensed one or more physiological signals; and

a command/parameter producer configured to produce one or more protocol execution commands and the one or more protocol generation parameters using the one or more user commands, the one or more user parameters, and the one or more physiological parameters,

and wherein the pacing control circuit is programmed to initiate and terminate the execution of the current pacing protocol in response to the one or more protocol execution commands.

11. A method for cardiac pacing, comprising:

receiving at least one pacing post-conditioning (PPC) protocol from a storage device storing one or more PPC protocols each specifying a pacing sequence, the pacing sequence including alternating non-pacing and pacing periods, the non-pacing periods each including a non-pacing duration during which no pacing pulse is timed to be delivered, the pacing periods each including a pacing duration during which a plurality of pacing pulses is timed to be delivered according to a stress augmentation pacing mode adapted to augment myocardial mechanical stress to a level effecting cardio protection against myocardial injury;

receiving one or more protocol generation parameters including at least one or more physiological parameters;

generating a current pacing protocol specifying a plurality of pacing parameters using the at least one PPC protocol and the one or more protocol generation parameters, including calculating one or more pacing parameters of the plurality of pacing parameters using the one or more protocol generation parameters;

controlling delivery of pacing pulses from a cardiac pacemaker by executing the current pacing protocol.

12. The method of claim 11, wherein receiving one or more protocol generation parameters comprises receiving a heart rate.

13. The method of claim 12, wherein the one or more PPC protocols comprises a plurality of PPC protocols, and generating the current pacing protocol comprises selecting a protocol from the plurality of PPC protocols using the heart rate.

14. The method of claim 13, wherein generating the current pacing protocol comprises setting a pacing rate of the plurality of pacing parameters to a value exceeding the heart rate by a specified margin.

15. The method of claim 11, wherein receiving one or more protocol generation parameters comprises receiving one or more parameters indicative of a type of arrhythmia, and generating the current pacing protocol comprises selecting a protocol from the plurality of PPC protocols based on the type of arrhythmia.

16. The method of claim 11, comprising

counting a number of cycles each including a non-pacing period followed by a pacing period;

and

terminating the execution of the current pacing protocol in response to the counted number of cycles reaching a specified number.

17. The method of claim 11, comprising

timing at least one of a total pacing duration and a total therapy duration, the total pacing duration being a sum of the pacing periods in the pacing sequence, the total therapy duration being a sum of the pacing periods and non-pacing periods in the pacing sequence;

and

terminating the execution of the current pacing protocol in response to at least one of the total pacing duration exceeding a specified minimum pacing time and the total therapy duration exceeding a specified minimum therapy time.

18. The method of claim 11, comprising:

verifying whether each of the delivered pacing pulses results in a captured beat being a cardiac depolarization resulting from the each of the delivered pacing pulses;

counting a number of the captured beats; and

terminating the execution of the current pacing protocol in response to the number of the captured beats detected during the pacing periods in the pacing sequence exceeding a specified minimum number of captured beats.

19. The method of claim 11, wherein receiving the at least one PPC protocol from the storage device comprises receiving the at least one PPC protocol from a pacing protocol module externally attached to the cardiac pacemaker, and comprising initiating the executing the current pacing protocol in response to an initiation command received by a user interface device incorporated onto a chassis of the cardiac pacemaker.

20. The method of claim 19, comprising terminating the executing the current pacing protocol in response to a termination command received by the user interface device.