System and apparatus to monitor biopacemaker maturation

• US 8,639,323 B2
• Filed: 11/01/2010
• Issued: 01/28/2014
• Est. Priority Date: 11/01/2010
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Sharma, Vinod, Jaye, Deborah A., Sigg, Daniel
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): CAREY, MICHAEL JAMES
• Application Number:
  US12/917,062
• Publication Number:
  US 20120109231A1
• Time in Patent Office: 1,184 Days
• Field of Search: 607/3, 607/27, 607/28, 607/19
• US Class Current: 607/3
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/364 Detecting abnormal ECG interval, e.g. extrasystoles, ectopic heartbeats
• CPC Class Codes: A61B 5/4848 Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/7232 involving compression of the physiological signal, e.g. to extend the signal recording period
• CPC Class Codes: A61K 48/005 characterised by an aspect of the 'active' part of the composition delivered, i.e. the nucleic acid delivered
• CPC Class Codes: A61N 1/3629 in combination with non-electric therapy
• CPC Class Codes: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: G16H 15/00 ICT specially adapted for medical reports, e.g. generation or transmission thereof
• 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

Abstract

The present invention includes systems, devices, and methods relating to the monitoring of the functional maturation of biological interventions effecting cardiac pacing; the systems, devices, and methods including an implantable electronic pulse generator delivering artificial cardiac pacing; a means for halting the electronic pulse generator delivering artificial cardiac pacing at predetermined data collection intervals; and a sensor for recording and storing data on one or more intrinsic physiological parameters of cardiac pacing during the predetermined data collection intervals.

Claims

1. A system for monitoring the functional effect of an intervention effecting cardiac pacing, the system comprising:

an implantable electronic pulse generator delivering artificial cardiac pacing;

a means for halting the electronic pulse generator delivering artificial cardiac pacing at predetermined data collection intervals;

a sensor for obtaining data on one or more intrinsic physiological parameters of cardiac pacing during the predetermined data collection intervals; and

a computer readable medium programmed with instructions, the instructions comprising;

instructions for recording and storing reference data for one or more intrinsic physiological parameters of cardiac pacing prior to the intervention effecting cardiac pacing;

wherein the reference data recorded and stored for one or more intrinsic physiological parameters of cardiac pacing prior to the intervention effecting cardiac pacing comprises a response to artificial cardiac pacing at the intervention site;

wherein the intervention effecting cardiac pacing comprises gene therapy, cell therapy, ablation, and/or drug delivery;

instructions for halting the electronic pulse generator delivering artificial cardiac pacing at predetermined data collection intervals after the intervention effecting cardiac pacing; and

instructions for obtaining data on one or more intrinsic physiological parameters of cardiac pacing during the predetermined data collection interval.

2. The system of claim 1 further comprising an external device that provides:

instructions for halting the electronic pulse generator delivering artificial cardiac pacing at predetermined data collection intervals; and

instructions for obtaining data on one or more intrinsic physiological parameters of cardiac pacing during the predetermined data collection intervals.

3. The system of claim 1 further comprising an external device that receives data on the one or more intrinsic physiological parameters of cardiac pacing and presents the data to a user.

7. The system of claim 1, wherein obtaining data on one or more intrinsic physiological parameters of cardiac pacing is initiated after a predefined interval after the halting of the artificial pacing provided by the implantable electronic pulse generator.

8. The system of claim 1, wherein the gene therapy comprises providing a hyperpolarization-activated cyclic nucleotide-gated (HCN) channel gene construct.

9. The system of any claim 1, wherein the intervention effecting cardiac pacing comprises cell therapy.

10. The system of claim 9, wherein the cell therapy comprises stem cell therapy or genetically modified cell therapy.

11. The system of claim 1, wherein the implantable electronic pulse generator comprises a pacemaker, ICD, CRT, CRT-D, SubQ ICD, intravascular pacemaker/ICD, and/or miniaturized leadless pacemaker.

12. The system of claim 1, wherein the instructions for recording and storing reference data for one or more intrinsic physiological parameters of cardiac pacing prior to the intervention effecting cardiac pacing, for halting the electronic pulse generator delivering artificial cardiac pacing at predetermined data collection intervals after the intervention effecting cardiac pacing, and/or instructions for obtaining data on one or more intrinsic physiological parameters of cardiac pacing during the predetermined data collection interval are executed on a processing circuit included within the implantable electronic pulse generator.

13. The system of claim 1, wherein the instructions for recording and storing reference data for one or more intrinsic physiological parameters of cardiac pacing prior to the intervention effecting cardiac pacing, for halting the electronic pulse generator delivering artificial cardiac pacing at predetermined data collection intervals after the intervention effecting cardiac pacing, and/or instructions for obtaining data on one or more intrinsic physiological parameters of cardiac pacing during the predetermined data collection interval are executed on a processing circuit included external to the implantable electronic pulse generator.

14. The system of claim 1 further comprising a means for storing the data on one or more intrinsic physiological parameters of cardiac pacing in memory of the implantable electronic pulse generator.

15. The system of claim 14 further comprising a means for the transmission of stored data to an external device.

16. The system of claim 15, wherein transmission of the stored data comprises uplink telemetry.

17. The system of claim 1 further comprising a means for presenting data on one or more intrinsic physiological parameters of cardiac pacing to a user.

18. The system of claim 1, wherein an intrinsic physiological parameter of cardiac pacing is indicative of the establishment of an exogenous biopacing intervention.

19. The system of claim 1, wherein an intrinsic physiological parameter of cardiac pacing further comprises an electrogram (EGM), pressure, or cardiac contractability.

20. The system of claim 1, wherein artificial pacing is halted for a period of about 30 seconds to about 180 seconds.

21. The system of claim 20, wherein data on one or more intrinsic physiological parameters of cardiac pacing is obtained after a predefined interval after halting artificial pacing.

22. The system of claim 1 comprising monitoring the response of the intervention effecting cardiac pacing to cardiac autonomic function.

26. The system of claim 1, further comprising an intrinsic physiological parameter of cardiac pacing selected from the group consisting of an injection site pacing electrogram, an intrinsic electrogram, an escape electrogram, and an ectopic beat electrogram.

27. The system of claim 1, wherein the system provides for displaying a stored intrinsic physiological parameter of cardiac pacing prior to the intervention effecting cardiac pacing in comparison to the data obtained on one or more intrinsic physiological parameters of cardiac pacing during the predetermined data collection interval.

34. The system of claim 1, further comprising instructions for recording and storing event triggered data.

4. A system for monitoring the functional effect of an intervention effecting cardiac pacing, the system comprising:

an implantable medical device (IMD) comprising an electronic pulse generator delivering artificial cardiac pacing, a means of halting the electronic pulse generator delivering artificial cardiac pacing at predetermined data collection intervals, and one or more sensors for obtaining data on one or more intrinsic physiological parameters of cardiac pacing during the predetermined data collection intervals; and

a computer readable medium programmed with instructions, the instructions comprising;

instructions for recording and storing reference data for one or more intrinsic physiological parameters of cardiac pacing prior to the intervention effecting cardiac pacing;

wherein the reference data recorded and stored for one or more intrinsic physiological parameters of cardiac pacing comprises a response to artificial cardiac pacing at the intervention site,

wherein the intervention effecting cardiac pacing comprises gene therapy, cell therapy, ablation, and/or drug delivery,

instructions for halting artificial pacing provided by the IMD at predetermined data collection intervals after the intervention effecting cardiac pacing,

instructions for recording the data on one or more intrinsic physiological parameters of cardiac pacing, and

instructions for resuming artificial pacing provided by the IMD.

5. The system of claim 4 further comprising an external device that provides instruction to the IMD for turning on or off the electronic pulse generator delivering artificial cardiac pacing halting and for obtaining data.

6. The system of claim 4 further comprising an external device that receives data on the one or more intrinsic physiological parameters of cardiac pacing and presents the data to a user.

35. The system of claim 4, further comprising instructions for recording and storing event triggered data.

23. A method of monitoring the functional effect of an intervention effecting cardiac pacing, the method comprising:

recording and storing reference data for one or more intrinsic physiological parameters of cardiac pacing prior to the intervention effecting cardiac pacing;

wherein the reference data recorded and stored for one or more intrinsic physiological parameters of cardiac pacing prior to the intervention effecting cardiac pacing a response to artificial cardiac pacing at the intervention site;

wherein the intervention effecting cardiac pacing comprises gene therapy, cell therapy, ablation, and/or drug delivery;

halting artificial pacing provided by an implantable electronic pulse generator to a heart subject to an intervention effecting cardiac pacing at predetermined data collection intervals after the intervention effecting cardiac pacing; and

obtaining data on one or more intrinsic physiological parameters of cardiac pacing in the heart subject to an intervention effecting cardiac pacing during the predetermined data collection intervals.

28. The method of claim 23, further comprising an intrinsic physiological parameter of cardiac pacing selected from the group consisting of an injection site pacing electrogram, an intrinsic electrogram, an escape electrogram, and an ectopic beat electrogram.

29. The method of claim 23, further comprising displaying a stored intrinsic physiological parameter of cardiac pacing prior to the intervention effecting cardiac pacing in comparison to the data obtained on one or more intrinsic physiological parameters of cardiac pacing during the predetermined data collection interval.

36. The methods system of claim 23, further comprising recording and storing event triggered data.

39. The method of claim 23, wherein the gene therapy comprises providing a hyperpolarization-activated cyclic nucleotide-gated (HCN) channel gene construct.

24. A method of monitoring the functional effect of an intervention effecting cardiac pacing, the method comprising:

recording and storing reference data for one or more intrinsic physiological parameters of cardiac pacing prior to the intervention effecting cardiac pacing;

wherein the reference data recorded and stored for one or more intrinsic physiological parameters of cardiac pacing prior to the intervention effecting cardiac pacing comprises a response to artificial cardiac pacing at the intervention site;

wherein the intervention effecting cardiac pacing comprises gene therapy, cell therapy, ablation, and/or drug delivery;

providing one or more interventions that effect cardiac pacing;

halting at predetermined data collection intervals after the intervention effecting cardiac pacing the artificial pacing provided by the implantable electronic pulse generator; and

obtaining data on one or more intrinsic physiological parameters of cardiac pacing during the predetermined data collection intervals.

32. The method of claim 24, further comprising an intrinsic physiological parameter of cardiac pacing selected from the group consisting of an injection site pacing electrogram, an intrinsic electrogram, an escape electrogram, and an ectopic beat electrogram.

33. The method of claim 24, further comprising displaying a stored intrinsic physiological parameter of cardiac pacing prior to the intervention effecting cardiac pacing in comparison to the data obtained on one or more intrinsic physiological parameters of cardiac pacing during the predetermined data collection interval.

37. The method of claim 24, further comprising recording and storing event triggered data.

25. A computer program product in non- transitory, computer-readable recordable type medium, the computer program product comprising:

instructions for recording and storing reference data for one or more intrinsic physiological parameters of cardiac pacing prior to the intervention effecting cardiac pacing;

wherein the reference data recorded and stored for one or more intrinsic physiological parameters of cardiac pacing prior to the intervention effecting cardiac pacing comprises a response to artificial cardiac pacing at the intervention site;

wherein the intervention effecting cardiac pacing comprises gene therapy, cell therapy, ablation, and/or drug delivery;

instructions for an electronic pulse generator to deliver artificial cardiac pacing;

instructions for halting the electronic pulse generator delivering artificial cardiac pacing at predetermined data collection intervals after the intervention effecting cardiac pacing; and

instructions for obtaining data on one or more intrinsic physiological parameters of cardiac pacing during the predetermined data collection intervals.

30. The computer program product of claim 25, further comprising an intrinsic physiological parameter of cardiac pacing selected from the group consisting of an injection site pacing electrogram, an intrinsic electrogram, an escape electrogram, and an ectopic beat electrogram.

31. The computer program product of claim 25, wherein the computer program product provides for displaying a stored intrinsic physiological parameter of cardiac pacing prior to the intervention effecting cardiac pacing in comparison to the data obtained on one or more intrinsic physiological parameters of cardiac pacing during the predetermined data collection interval.

38. The computer program product of claim 25, further comprising instructions for recording and storing event triggered data.