Rate responsive leadless cardiac pacemaker

• US 9,072,913 B2
• Filed: 04/29/2011
• Issued: 07/07/2015
• 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): Patel, Niketa
• Assistant Examiner(s): LEVICKY, WILLIAM J
• Application Number:
  US13/098,266
• Publication Number:
  US 20110208260A1
• Time in Patent Office: 1,530 Days
• Field of Search: 607/9, 607/27, 607/32, 607/119, 607/122, 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

A leadless cardiac pacemaker comprises a housing, a plurality of electrodes coupled to an outer surface of the housing, and a pulse delivery system hermetically contained within the housing and electrically coupled to the electrode plurality, the pulse delivery system configured for sourcing energy internal to the housing, generating and delivering electrical pulses to the electrode plurality. The pacemaker further comprises an activity sensor hermetically contained within the housing and adapted to sense activity and a processor hermetically contained within the housing and communicatively coupled to the pulse delivery system, the activity sensor, and the electrode plurality, the processor configured to control electrical pulse delivery at least partly based on the sensed activity.

Claims

1. A method of pacing a patient'"'"'s heart, comprising:

sensing a parameter with a sensor hermetically contained within a housing of a leadless pacemaker implanted in the heart, wherein the leadless pacemaker comprises a plurality of electrodes formed integrally to the housing or coupled to the housing at a maximum distance of 2 centimeters;

generating electrical pulses with a pulse delivery system hermetically contained within the housing of the leadless pacemaker;

delivering the electrical pulses through the electrodes of the leadless pacemaker to stimulate the heart at least partly based on the sensed parameter;

generating encoded information signals within the leadless pacemaker;

directly communicating the encoded information signals from the leadless pacemaker during a cardiac refractory period of the heart to a device external to the patient through the electrodes of the leadless pacemaker; and

sourcing energy of no more than 75-80 microwatts instantaneously for generating the electrical pulses using a battery, wherein the peak power of the leadless pacemaker is less than or equal to 74 microwatts.

2. The method of claim 1 wherein the delivering step further comprises delivering the electrical pulses to the heart through electrodes of the leadless pacemaker at least partly based on the sensed parameter and partly based on communication signals received via the electrodes.

3. The method of claim 1 wherein the sensing step further comprises sensing temperature with the sensor of the leadless pacemaker.

4. The method of claim 1 wherein the sensing step further comprises sensing pressure with the sensor of the leadless pacemaker.

5. The method of claim 1 wherein the information signals are selected from a group consisting of programmable parameter settings, event counts, power-supply voltage, power-supply current, and rate-response control parameters adapted for converting a sensor signal to a rate-responsive pacing parameter.

6. The method of claim 1 wherein the communicating step further comprises communicating encoded information signals to the device in designated codes encoding the information in pacing pulse width.

7. The method of claim 1 further comprising:

invoking a low-gain setting in a receiving amplifier/filter of the leadless pacemaker for normal operation and detecting presence of at least one pulse; and

invoking a high-gain setting for detecting and decoding information encoded in the detected at least one pulse.

8. The method of claim 1, wherein the step of generating encoded information signals within the leadless pacemaker-comprises generating notches in at least one timing window of at least one pacing pulse as the encoded information.

9. A method of pacing a patient'"'"'s heart, comprising:

sensing a parameter with a sensor hermetically contained within a housing of a leadless pacemaker implanted in the heart, wherein the leadless pacemaker comprises a plurality of electrodes formed integrally to the housing or coupled to the housing at a maximum distance of 2 centimeters;

generating electrical pulses with a pulse delivery system hermetically contained within the housing of the leadless pacemaker;

delivering the electrical pulses through the electrodes of the leadless pacemaker to stimulate the heart at least partly based on the sensed parameter;

generating encoded information signals within the leadless pacemaker;

directly communicating the encoded information signals from the leadless pacemaker during a cardiac refractory period of the heart to a device external to the patient through the electrodes of the leadless pacemaker, wherein the sensor is configured to operate with a power requirement of no more than 10 microwatts.