Programmer for biostimulator system

• US 20070088405A1
• Filed: 10/13/2006
• Published: 04/19/2007
• Est. Priority Date: 10/14/2005
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Original Assignee: Nanostim, Inc (Abbott Laboratories)
• Inventors: Jacobson, Peter
• Granted Patent: US 7,945,333 B2
• Time in Patent Office: Days
• US Class Current: 607/59
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/0573 chacterised by means penetrating the heart tissue, e.g. helix needle or hook
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• CPC Class Codes: A61N 1/059 Anchoring means
• CPC Class Codes: A61N 1/3621 for treating or preventing abnormally high heart rate
• 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 1/36514 controlled by a physiological quantity other than heart potential, e.g. blood pressure controlled by two or more physical parameters A61N1/36585
• CPC Class Codes: A61N 1/36542 controlled by body motion, e.g. acceleration
• 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 1/3684 for stimulating the heart at multiple sites of the ventricle or the atrium
• CPC Class Codes: A61N 1/36842 Multi-site stimulation in the same chamber
• CPC Class Codes: A61N 1/3704 Circuits specially adapted therefor, e.g. for sensitivity control
• CPC Class Codes: A61N 1/3706 Pacemaker parameters stimulation threshold A61N1/371
• CPC Class Codes: A61N 1/3708 for power depletion
• CPC Class Codes: A61N 1/372 Arrangements in connection with the implantation of stimulators
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/37217 characterised by the communication link, e.g. acoustic or tactile
• CPC Class Codes: A61N 1/37252 Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
• CPC Class Codes: A61N 1/3727 characterised by the modulation technique
• CPC Class Codes: A61N 1/37288 : Communication to several implantable medical devices within one patient
• CPC Class Codes: A61N 1/37512 : Pacemakers
• CPC Class Codes: A61N 1/37518 : Anchoring of the implants, e.g. fixation
• CPC Class Codes: A61N 1/3756 : Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 1/3925 : Monitoring; Protecting
• CPC Class Codes: A61N 1/3956 : Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
• CPC Class Codes: A61N 1/39622 : Pacing therapy
• CPC Class Codes: A61N 2001/058 : Fixing tools
• CPC Class Codes: H04B 13/005 : Transmission systems in which the medium consists of the human body

Abstract

A biostimulator system comprises one or more implantable devices and an external programmer configured for communicating with the implantable device or devices via bidirectional communication pathways comprising a receiving pathway that decodes information encoded on stimulation pulses generated by ones of the implantable device or devices and conducted through body tissue to the external programmer.

Claims

1. An external programmer adapted for communicating with an implanted biostimulator system comprising:

an interface configured for coupling to at least two electrodes that make electrical contact with body skin for communicating with at least one implanted biostimulator; and

bidirectional communication pathways coupled to the interface configured for bidirectional communication with the at least one implanted biostimulator and comprising a receiving pathway that decodes information encoded on stimulation pulses generated by the at least one implanted biostimulator and conducted through body tissue.

2. The programmer according to claim 1 further comprising:

the bidirectional communication pathways further comprising a transmitting pathway that passes information from the programmer to the at least one implanted biostimulator by conduction through the body tissue by modulation that avoids skeletal muscle stimulation.

3. The programmer according to claim 1 further comprising:

a processor coupled to the bidirectional communication pathways and configured to manage communication with at least one leadless cardiac pacemaker.

4. The programmer according to claim 1 further comprising:

a processor coupled to the bidirectional communication pathways and configured to manage communication with at least one leadless cardiac pacemaker implanted adjacent to an inside or an outside wall of a cardiac chamber.

5. The programmer according to claim 1 further comprising:

a processor coupled to the bidirectional communication pathways and configured to perform at least one operation of operations comprising electrocardiogram sensing, retrieving status information from implanted pacemakers, and modifying configuration parameters of multiple implanted pacemakers within a single or multiple cardiac cycles in information passed through a common electrode set; and

a display interface coupled to the processor and configured to display an electrocardiogram sensed from the at least two electrodes.

6. The programmer according to claim 1 further comprising:

a processor coupled to the bidirectional communication pathways and configured to perform at least one operation of operations comprising electrocardiogram sensing, retrieving status information from implanted pacemakers, and modifying configuration parameters of multiple implanted pacemakers within a single or multiple cardiac cycles in information passed through a common electrode set; and

a secondary link coupled to the processor and configured for wireless or cable transmission to a remote display device to display an electrocardiogram sensed from the at least two electrodes.

7. The programmer according to claim 1 further comprising:

the bidirectional communication pathways configured for communication with a plurality of leadless cardiac pacemakers via the at least two electrodes and conduction through body tissue.

8. The programmer according to claim 1 further comprising:

the bidirectional communication pathways further comprising a transmitting pathway that passes information from the programmer to the at least one implanted biostimulator by direct conduction using modulated signals at a frequency in a range from approximately 10 kHz to 100 kHz.

9. The programmer according to claim 1 further comprising:

the at least two electrodes and the bidirectional communication pathways configured for bidirectional information signal communication and for sensing an electrocardiogram, the bidirectional communication pathways comprising a receiving pathway including a low-pass filter adapted to separate the electrocardiogram from the information signals.

10. The programmer according to claim 1 further comprising:

the at least two electrodes and the bidirectional communication pathways configured for bidirectional information signal communication and for sensing an electrocardiogram, the bidirectional communication pathways comprising a receiving pathway including a low-pass filter adapted to separate the electrocardiogram from the information signals and a blanking controller configured to blank noise and unwanted signals from the electrocardiogram when the communication channel is active.

11. The programmer according to claim 1 wherein:

the at least two electrodes comprise more than two electrodes enabling an electrocardiogram (ECG) to be sensed at multiple vectors and selection from among the multiple vectors for conducted communication with the at least one leadless cardiac pacemaker whereby system signal-to-noise ratio can be maximized.

12. The programmer according to claim 1 further comprising:

the bidirectional communication pathways further comprising a transmitting pathway that passes information from the programmer to a plurality of implanted devices in a common communication event.

13. The programmer according to claim 1 further comprising:

the bidirectional communication pathways further comprising a transmitting pathway that passes information from the programmer to a plurality of implanted devices in a common communication event whereby information specific to a single implanted device or a subset of implanted devices have a unique address assigned to the single implanted device or the subset of implanted devices and encoded in the information.

14. The programmer according to claim 1 further comprising:

the bidirectional communication pathways further comprising a transmitting pathway that passes information from the programmer to a plurality of implanted devices in a common communication event whereby information designates a specific function that is executed by a particular implanted device or a particular subset of implanted devices, the information being passed to the implanted device plurality without individual address information for activating execution by the particular implanted device or the particular subset of implanted devices alone.

15. The programmer according to claim 1 further comprising:

the bidirectional communication pathways further comprising a transmitting pathway that passes information from the programmer to a plurality of implanted devices in a common communication event whereby information designates a specific function that is executed by a particular implanted device or a particular subset of implanted devices that comprise programming specific to the function adapted to recognize the received information is relevant to the function.

16. The programmer according to claim 1 further comprising:

the at least two electrodes forming a conductive communication path between the programmer and a skin surface; and

the receiving pathway comprising;

an electrocardiogram (ECG) amplifier/filter comprising a differential band-pass amplifier configured to select and amplify signals in a frequency range from approximately 1 Hz to approximately 100 Hz;

an analog-to-digital converter (ADC) configured to digitize the filtered and amplified signal; and

a processor coupled to the ADC configured to receive and optionally display ECG data, and configured to decode information encoded into cardiac pacing pulses.

17. The programmer according to claim 1 further comprising:

the at least two electrodes forming a conductive communication path between the programmer and a skin surface; and

the bidirectional communication pathways further comprising a transmitting pathway comprising;

a processor configured to communicate information to at least one implanted leadless cardiac pacemaker;

a command/message encoder coupled to the processor via a parallel interface and configured to encode and serialize data into a bit stream, the encoding being selected from a group of encoding techniques consisting of on-off keying, frequency-shift keying, frequency modulation, and amplitude shift keying;

a modulator coupled to the command/message encoder that receives and modulates the serialized data using a frequency in a range from approximately 10 kHz to approximately 100 kHz; and

an amplifier coupled to the modulator that increases signal amplitude to a level suitable for robust conducted communication.

18. The programmer according to claim 1 further comprising:

the receiving pathway that decodes information in a group consisting of encoded using pacing pulse width, encoded using binary-coded notches in a pacing pulse, and encoded using modulation of off-time between pacing pulses.

19. A biostimulator system comprising:

at least one implantable device; and

an external programmer configured for communicating with the at least one implantable device via bidirectional communication pathways comprising a receiving pathway that decodes information encoded on stimulation pulses generated by ones of the at least one implantable device and conducted through body tissue to the external programmer.

20. The system according to claim 19 further comprising:

the bidirectional communication pathways further comprising a transmitting pathway that passes information from the external programmer to ones of the at least one implantable device by direct conduction through the body tissue by modulation that avoids skeletal muscle stimulation using modulated signals at a frequency in a range from approximately 10 kHz to 100 kHz.

21. The system according to claim 19 further comprising:

the bidirectional communication pathways further comprising a transmitting pathway that passes information from the programmer to the at least one implantable device in a common communication event whereby information is sent to at least one target device of the at least one implantable device using a technique selected from a group consisting of;

information specific to a single implantable device or a subset of implantable devices having a unique address assigned to the single implantable device or the subset of implantable devices and encoded in the information;

information designating a specific function that is executed by a particular implantable device or a particular subset of implantable devices, the information being passed to the at least one implantable device without individual address information for activating execution by the particular implantable device or the particular subset of implantable devices alone; and

information designates a specific function that is executed by a particular implantable device or a particular subset of implantable devices that comprise programming specific to the function adapted to recognize the received information is relevant to the function.

22. The system according to claim 19 further comprising:

the bidirectional communication pathways further comprising a receiving pathway including a low-pass filter adapted to separate the electrocardiogram from the information signals.

23. The system according to claim 19 further comprising:

the bidirectional communication pathways further comprising a receiving pathway including a low-pass filter adapted to separate the electrocardiogram from the information signals and a blanking controller configured to blank noise and unwanted signals from the electrocardiogram when the communication channel is active.

24. The system according to claim 19 further comprising:

the external programmer further configured to perform at least one operation of operations comprising electrocardiogram sensing, retrieving status information from implanted pacemakers, modifying configuration parameters of multiple implanted pacemakers simultaneously in information passed through a common electrode set, displaying electrocardiograms, and displaying information received from the at least one implantable device.

25. The system according to claim 19 further comprising:

the at least one implantable device comprising at least one leadless cardiac pacemaker.

26. The system according to claim 19 further comprising:

the at least one implantable device comprising at least one leadless cardiac pacemaker implanted adjacent to an inside or an outside wall of a cardiac chamber.

27. The system according to claim 19 wherein:

the bidirectional communication pathways are configured for communication with a plurality of leadless cardiac pacemakers via at least two electrodes and conduction through body tissue.

28. The system according to claim 19 further comprising:

the at least one implantable device comprising at least one leadless cardiac pacemaker that generates cardiac pacing pulses, encodes information onto the generated cardiac pacing pulses by selective alteration of pacing pulse morphology that is benign to therapeutic effect and energy cost of the pacing pulse, and conducts the cardiac pacing pulses into body tissue via electrodes for antenna-less and telemetry coil-less communication.

29. The system according to claim 28 further comprising:

the at least one leadless cardiac pacemaker configured to detect a natural cardiac depolarization, time a selected delay interval, and deliver an information-encoded pulse during a refractory period following the natural cardiac depolarization.

30. The system according to claim 28 wherein:

the encoded information selected from a group consisting of pacemaker state information, battery voltage, lead impedance, sensed cardiac signal amplitude, pacemaker current drain, and programmed parameters.

31. The system according to claim 28 further comprising:

the at least one leadless cardiac pacemaker configured to charge a tank capacitor in preparation for stimulation pulse generation, time one or more windows between pulse generation, disable charging of the tank capacitor during the one or more timed windows, and enable a receive amplifier in the implanted biostimulator while the tank capacitor is disabled.

32. The system according to claim 31 further comprising:

the external programmer further configured to detect a stimulation pulse from the at least one leadless cardiac pacemaker and transmit data after a selected delay to coincide with a window that the at least one leadless cardiac pacemaker'"'"'s receive amplifier is enabled.

33. A method for communicating in an implantable biostimulator system comprising:

monitoring, at an external programmer, electrical signals conducted through body tissue to body surface electrodes;

detecting pulses generated by a body-implanted biostimulator; and

decoding information encoded into the generated pulse by the body-implanted biostimulator.

34. The method according to claim 33 further comprising:

generating cardiac pacing pulses at an implanted leadless cardiac pacemaker;

encoding information onto generated cardiac pacing pulses at the implanted leadless cardiac pacemaker by selective alteration of pacing pulse morphology that is benign to therapeutic effect and energy cost of the pacing pulse; and

conducting the cardiac pacing pulses into body tissue via electrodes for antenna-less and telemetry coil-less communication.

35. The method according to claim 33 further comprising:

generating cardiac pacing pulses at an implanted leadless cardiac pacemaker; and

encoding information onto generated cardiac pacing pulses at the implanted leadless cardiac pacemaker comprising at least one of pacemaker state information, battery voltage, lead impedance, sensed electrocardiogram amplitude, pacemaker current drain, and programmed parameters.

36. The method according to claim 33 further comprising:

generating cardiac pacing pulses at an implanted leadless cardiac pacemaker;

encoding information onto generated cardiac pacing pulses at the implanted leadless cardiac pacemaker by selective alteration of pacing pulse morphology that is benign to therapeutic effect and energy cost of the pacing pulse;

detecting at the implanted leadless cardiac pacemaker a natural cardiac depolarization;

inhibiting cardiac pacing pulse delivery with delay for delivery during a refractory period following the natural cardiac depolarization; and

conducting the cardiac pacing pulses into body tissue via electrodes for antenna-less and telemetry coil-less communication.

37. The method according to claim 33 further comprising:

generating stimulation pulses on stimulating electrodes of an implanted biostimulator; and

encoding information onto generated stimulation pulses comprising gating the stimulation pulses for selected durations at selected timed sections in the stimulation pulses whereby gating removes current flow through the stimulating electrodes and timing of the gated sections encodes the information.

38. The method according to claim 33 further comprising:

generating stimulation pulses on stimulating electrodes of an implanted biostimulator; and

encoding information in pulse width of generated stimulation pulses.

39. The method according to claim 33 further comprising:

generating stimulation pulses on stimulating electrodes of an implanted biostimulator; and

encoding information onto generated stimulation pulses comprising selectively varying timing between consecutive stimulation pulses.

40. The method according to claim 33 further comprising:

distinguishing a generated cardiac pacing pulse from a natural cardiac depolarization in an electrocardiogram comprising comparative pattern recognition of a pacing pulse and an R-wave produced during a cardiac cycle.

41. The method according to claim 33 further comprising:

charging a tank capacitor in preparation for stimulation pulse generation;

generating stimulation pulses on stimulating electrodes of an implanted biostimulator;

encoding information onto generated stimulation pulses;

timing one or more windows between pulse generations;

disabling charging of the tank capacitor during the one or more timed windows; and

enabling a receive amplifier in the implanted biostimulator while the tank capacitor is disabled.

42. The method according to claim 41 further comprising:

sensing, at the external programmer, stimulation pulses generated by the implanted biostimulator;

transmitting information from the external programmer to the implanted biostimulator to coincide with the one or more timed windows.

43. The method according to claim 41 further comprising:

detecting at the external programmer a stimulation pulse from the implanted biostimulator;

timing a selected delay; and

transmitting data after the selected delay to coincide with a window that the implanted biostimulator'"'"'s receive amplifier is enabled.

44. The method according to claim 33 further comprising:

physically connecting the external programmer to a body surface via at least two body surface electrodes;

communicating information among the external programmer and at least two implanted leadless cardiac pacemakers;

transmitting encoded information from the external programmer to the implanted leadless cardiac pacemakers via the at least two body surface electrodes using a modulated signal at a frequency in a range of approximately 10 kHz to approximately 100 kHz;

receiving information at the external programmer via the at least two body surface electrodes from ones of the at least two implanted leadless cardiac pacemakers comprising detecting information encoded into generated pacing pulses; and

receiving surface electrocardiogram at the external programmer via the at least two body surface electrodes for display and analysis.

45. The method according to claim 33 further comprising:

encoding and/or decoding information in a group consisting of encoded using pacing pulse width, encoded using binary-coded notches in a pacing pulse, and encoded using modulation of off-time between pacing pulses.

46. The method according to claim 33 further comprising:

detecting information carried on pacing pulses from a co-implanted device;

invoking a low-gain setting for a receiving amplifier for normal operation;

detecting a pacing pulse edge when in the low-gain setting;

invoking a high-gain setting for the receiving amplifier upon pacing pulse edge detection;

detecting and decoding information encoded on the pacing pulse using the high-gain receiving amplifier setting; and

reinvoking the low-gain receiving amplifier setting after the pacing pulse has ended.

47. The method according to claim 46 further comprising:

encoding information in a latter portion of the pacing pulse whereby a time interval between pacing pulse edge detection and the encoded information is sufficient to enable accurate transition to the high-gain receiving amplifier setting.

48. The method according to claim 33 further comprising:

charging a tank capacitor in preparation for stimulation pulse generation;

detecting a supply voltage drop below a prespecified level; and

terminating charging of the pacing tank capacitor when the supply voltage drops below the prespecified level.