Programmer for biostimulator system

• US 7,945,333 B2
• Filed: 10/13/2006
• Issued: 05/17/2011
• Est. Priority Date: 10/14/2005
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Original Assignee: Nanostim, Inc (Abbott Laboratories)
• Inventors: Jacobson, Peter M.
• Primary Examiner(s): Patel; Niketa I
• Assistant Examiner(s): EL-KAISSI, HIBA CARINE
• Application Number:
  US11/549,605
• Publication Number:
  US 20070088405A1
• Time in Patent Office: 1,677 Days
• Field of Search: 607 30- 32, 607/59, 607/60
• 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 adapted to make electrical contact with body skin for communicating with at least one implanted biostimulator;

bidirectional communication pathways coupled to the interface configured for bidirectional communication with the at least one implanted biostimulator and comprising a receiving pathway and a processor configured to sense an electrocardiogram with the at least two electrodes and to decode information encoded on pulses generated by the at least one implanted biostimulator and conducted through body tissue and received by the receiving pathway with the at least two electrodes.

2. The programmer according to claim 1 wherein:

the bidirectional communication pathways further comprise a transmitting pathway, the processor being further configured to pass information from the transmitting pathway and the at least two electrodes 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 wherein the processor is further configured to manage communication with at least one leadless cardiac pacemaker.

4. The programmer according to claim 1 wherein the processor is further 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 the claim 1 wherein the processor is further configured to perform at least one operation of operations comprising 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 the at least two electrodes;

and

the programmer further comprising 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 wherein the processor is further configured to perform at least one operation of operations comprising 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 the at least two electrodes;

and

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

the processor coupled to the ADC and configured to receive and optionally display ECG data.

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 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 encoded using pulse width.

19. The programmer according to claim 1 further comprising:

the receiving pathway configured to decode information encoded using binary-coded notches in a pulse.

20. The programmer according to claim 1 further comprising:

the receiving pathway configured to decode information encoded using modulation of off-time between pulses.