Leadless cardiac pacemaker

• US 9,358,400 B2
• Filed: 10/13/2006
• Issued: 06/07/2016
• Est. Priority Date: 10/14/2005
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Jacobson, Peter M.
• Primary Examiner(s): Flory, Christopher A
• Application Number:
  US11/549,581
• Publication Number:
  US 20070088396A1
• Time in Patent Office: 3,525 Days
• Field of Search: 607/9, 607/27, 607/32, 607/119, 607/122, 607/2, 607/28, 600/373, 600/374
• US Class Current: 1/1
• 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

In a cardiac pacing system, a leadless cardiac pacemaker is configured for implantation in electrical contact with a cardiac chamber and configured for leadless pacing.

Claims

1. A leadless biostimulator comprising:

a housing;

a plurality of electrodes formed integrally to the housing or coupled to the housing and separated by a maximum distance of 2 centimeters from the housing;

a pulse generator hermetically contained within the housing and electrically coupled to the electrode plurality, the pulse generator configured to generate and deliver electrical pulses via the electrode plurality;

a processor hermetically contained within the housing and communicatively coupled to the pulse generator and the electrode plurality, the processor being configured to control electrical pulse delivery according to programmed instructions; and

a power supply hermetically contained within the housing and coupled to the pulse generator, the power supply configured to supply energy for operations and electrical pulse generation as a source internal to the housing, the power supply further comprising a primary battery that has a volume less than approximately 1 cubic centimeter and sources sufficient energy for supporting circuitry that consumes a maximum of 64 microwatts, wherein the pulse generator is further configured to selectively generate and deliver electrical energy in a stimulation pulse to at least two of the electrode plurality for causing a contraction of a patient'"'"'s heart in response to control signals from the processor, the stimulation pulse being interrupted by at least one notch configured to convey information to a device external to the biostimulator.

2. The biostimulator according to claim 1, wherein

the processor is further configured to communicate control signals to the pulse generator specifying characteristics of the at least one notch and defining the conveyed information.

3. The biostimulator according to claim 1, wherein

the conveyed information comprises data selected from a group consisting of programmable parameter settings, event counts, power-supply voltage, and power-supply current.

4. The biostimulator according to claim 1,

wherein a width of the at least one notch is approximately 15 microseconds.

5. The biostimulator according to claim 1,

wherein the at least one notch occurs in at least one timing window.

6. The biostimulator according to claim 1,

wherein the at least one notch occurs in at least one timing window and spacing between timing windows is approximately 100 microseconds.

7. The biostimulator according to claim 1, wherein

the power supply further comprises a primary battery formed of a beta-voltaic converter configured to obtain electrical energy from radioactivity.

8. The biostimulator according to claim 1 further comprising:

a regulator circuit electrically connected between the power supply and biostimulator circuitry, the regulator circuit configured to regulate voltage supply for powering biostimulator circuitry.

9. The biostimulator according to claim 1, wherein the power supply further comprises a primary battery, and wherein the biostimulator further comprises a battery ammeter in the power supply configured for indicating battery current drain and indirect device health for usage by the processor.

10. The biostimulator according to claim 1, wherein the power supply further comprises a primary battery, and wherein the biostimulator further comprises a battery voltmeter in the power supply configured for indicating battery voltage for usage by the processor.

11. The biostimulator according to claim 1 further comprising:

a tissue connector adapted to affix the housing to cardiac muscle, the tissue connector selected from a group consisting of a helix configured to rotatingly advance into the cardiac muscle, at least one member pierced with a hole for passing a suture, and at least one tine.

12. The biostimulator according to claim 1 wherein:

the housing is cylindrical; and

the electrode plurality comprises annular electrodes located at extremities of the housing.

13. The biostimulator according to claim 1 wherein:

the housing is constructed from a ceramic material; and

the electrode plurality is deposited on the ceramic material.

14. The biostimulator according to claim 1 wherein:

the housing is operative as an electrode and constructed from titanium or stainless steel and is coated over part of an exterior surface with a silicone rubber or polyurethane insulating material.

15. The biostimulator according to claim 1 wherein:

the biostimulator is a leadless cardiac pacemaker.

16. A leadless biostimulator comprising:

a housing;

a plurality of electrodes formed integrally to the housing or coupled to the housing and separated by a maximum distance of 2 centimeters from the housing;

a pulse generator hermetically contained within the housing and electrically coupled to the electrode plurality, the pulse generator configured to generate and deliver electrical pulses via the electrode plurality;

a processor hermetically contained within the housing and communicatively coupled to the pulse generator and the electrode plurality, the processor being configured to control electrical pulse delivery according to programmed instructions; and

a power supply hermetically contained within the housing and coupled to the pulse generator, the power supply configured to supply energy for operations and electrical pulse generation as a source internal to the housing, the power supply further comprising a primary battery that has a volume less than approximately 1 cubic centimeter and sources sufficient energy for supporting circuitry that consumes a maximum of 64 microwatts, wherein the pulse generator is further configured to selectively generate and deliver electrical energy in a stimulation pulse to at least two of the electrode plurality for causing a contraction of a patient'"'"'s heart in response to control signals from the processor, wherein the pulse generator is further configured to generate and deliver electrical energy in a series of stimulation pulses with time between the stimulation pulses selectively varied to convey information to a device external to the biostimulator.

17. The biostimulator according to claim 16 wherein:

the variation of time between pulses is less than a total of 10 milliseconds.

18. A leadless biostimulator comprising:

a housing;

a plurality of electrodes formed integrally to the housing or coupled to the housing and separated by a maximum distance of 2 centimeters from the housing;

a pulse generator hermetically contained within the housing and electrically coupled to the electrode plurality, the pulse generator configured to generate and deliver electrical pulses via the electrode plurality;

a processor hermetically contained within the housing and communicatively coupled to the pulse generator and the electrode plurality, the processor being configured to control electrical pulse delivery according to programmed instructions; and

a power supply hermetically contained within the housing and coupled to the pulse generator, the power supply configured to supply energy for operations and electrical pulse generation as a source internal to the housing, the power supply further comprising a primary battery that has a volume less than approximately 1 cubic centimeter and sources sufficient energy for supporting circuitry that consumes a maximum of 64 microwatts, wherein the pulse generator is configured to generate and deliver electrical energy in a series of stimulation pulses with pacing pulse width selectively varied to convey information to a device external to the biostimulator.

19. A leadless biostimulator comprising:

a housing;

a plurality of electrodes formed integrally to the housing or coupled to the housing and separated by a maximum distance of 2 centimeters from the housing;

a pulse generator hermetically contained within the housing and electrically coupled to the electrode plurality, the pulse generator configured to generate and deliver electrical pulses via the electrode plurality;

a processor hermetically contained within the housing and communicatively coupled to the pulse generator and the electrode plurality, the processor being configured to control electrical pulse delivery according to programmed instructions;

a power supply hermetically contained within the housing and coupled to the pulse generator, the power supply configured to supply energy for operations and electrical pulse generation as a source internal to the housing, the power supply further comprising a primary battery that has a volume less than approximately 1 cubic centimeter and sources sufficient energy for supporting circuitry that consumes a maximum of 64 microwatts;

a receiving amplifier/filter adapted for multiple controllable gain settings; and

a processor configured to control gain setting for the receiving amplifier/filter, invoking a low-gain setting for normal operation and detecting presence of an electrical pulse, and invoking a high-gain setting for detecting and decoding information encoded in the detected electrical pulse.

20. The system according to claim 19 further comprising:

a tank capacitor coupled across a pair of the electrode plurality and adapted for charging and discharging wherein an electrical pulse is generated;

a charge pump circuit coupled to the tank capacitor and adapted for controlling charging of the tank capacitor; and

a processor configured to control recharging of the tank capacitor wherein recharging is discontinued when a battery terminal voltage falls below a predetermined value to ensure sufficient voltage for powering the leadless biostimulator.

21. A leadless cardiac pacemaker comprising:

a housing;

a plurality of electrodes formed integrally to the housing or coupled to the housing and separated by a maximum distance of 2 centimeters from the housing;

a pulse generator hermetically contained within the housing and electrically coupled to the electrode plurality, the pulse generator configured for generating and delivering electrical pulses to the electrode plurality and causing cardiac contractions, the pulse generator further configured to convey information to at least one device external to the pacemaker by conductive communication encoded on pulses via the electrode plurality;

at least one amplifier hermetically contained within the housing and electrically coupled to the electrode plurality, the at least one amplifier configured to amplify signals received from the electrode plurality and to detect cardiac contractions, the at least one amplifier further configured to receive information from the at least one external device;

a processor hermetically contained within the housing and communicatively coupled to the pulse generator, the at least one amplifier, and the electrode plurality, the processor configured to receive amplifier output signals from the amplifier, control communications, and control electrical pulse delivery according to programmed instructions; and

a power supply hermetically contained within the housing and coupled to the pulse generator, the power supply configured to supply energy for operations, communication, and electrical pulse generation as a source internal to the housing.

22. The pacemaker according to claim 21 further comprising:

the pulse generator configured to consume a maximum electrical power of 27 microwatts averaged over one cardiac cycle.

23. The pacemaker according to claim 21 further comprising:

the amplifier configured to consume a maximum electrical power of 30 microwatts.

24. The pacemaker according to claim 21 further comprising:

the power supply configured to consume a maximum electrical power of 2 microwatts and configured to supply a minimum electrical power of approximately 64 microwatts.

25. The pacemaker according to claim 21 further comprising:

the processor configured to consume a maximum electrical power of 5 microwatts averaged over one cardiac cycle.

26. A leadless biostimulator comprising:

a housing;

a plurality of electrodes formed integrally to the housing or coupled to the housing and separated by a maximum distance of 2 centimeters from the housing;

a pulse generator hermetically contained within the housing and electrically coupled to the electrode plurality, the pulse generator configured for generating and delivering electrical pulses to the electrode plurality; and

a processor hermetically contained within the housing and communicatively coupled to the pulse generator and the electrode plurality, the processor configured to control electrical pulse delivery and configured to communicate with at least one device external to the biostimulator by conductive communication signals encoded on pulses via the electrode plurality.

27. The biostimulator according to claim 26 further comprising:

the processor being configured to control electrical pulse delivery according to at least one programmable parameter, the processor configured to be programmable by conducted communication signals transmitted via the electrode plurality.

28. The biostimulator according to claim 26 further comprising:

the processor being configured to communicate to the at least one device external to the biostimulator by communication signals transmitted via the electrode plurality.

29. The biostimulator according to claim 26 wherein:

the biostimulator is a leadless cardiac pacemaker.