Leadless cardiac pacemaker

Patent metadata

Field	Value
Publication number	US-9358400-B2
Application number	US-54958106-A
Country	US
Kind code	B2
Filing date	Oct 13, 2006
Priority date	Oct 14, 2005
Publication date	Jun 7, 2016
Grant date	Jun 7, 2016

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.

First claim

What is claimed is:

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.

Assignees

• Jacobson Peter M
• Pacesetter Inc

Inventors

• Jacobson Peter M

Classifications

• A61N1/3684

  for stimulating the heart at multiple sites of the ventricle or the atrium · CPC title

• A61N1/37217

  characterised by the communication link, e.g. acoustic or tactile · CPC title

• A61N1/3621

  for treating or preventing abnormally high heart rate · CPC title

• H04B13/005

  Transmission systems in which the medium consists of the human body · CPC title

• A61N1/368

  comprising more than one electrode co-operating with different heart regions {(A61N1/3622, A61N1/3627 take precedence)} · CPC title