Implantable medical device with wireless communications

• US 8,401,659 B2
• Filed: 01/15/2009
• Issued: 03/19/2013
• Est. Priority Date: 01/15/2008
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Von Arx, Jeffrey Allen, Chavan, Abhi V.
• Primary Examiner(s): STOKLOSA, JOSEPH A
• Application Number:
  US12/354,490
• Publication Number:
  US 20090182388A1
• Time in Patent Office: 1,524 Days
• Field of Search: 607 30- 32, 607 59- 60
• US Class Current: 607/60
• CPC Class Codes: A61B 2560/0214 of power generation or supply
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/085 Measuring impedance of respiratory organs or lung elasticity
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61N 1/37229 Shape or location of the implanted or external antenna
• CPC Class Codes: A61N 1/37282 characterised by communication with experts in remote locations using a network
• CPC Class Codes: A61N 1/378 Electrical supply
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

An implantable medical device for use in a patient management system is described, including a sensor capable of measuring a body characteristic and generating a data signal describing the measurement, and a processor configured to analyze the data signal and identify one or more significant events that warrant attention for the well-being of a patient. The implantable medical device further includes a first non-rechargeable battery configured to power at least the sensor and the processor. In addition, a first communications unit is configured to be powered by the first non-rechargeable battery and includes a wireless transmitter capable of establishing a first communications link with a host computer using an external local receiver, when said first wireless transmitter is within a short-range telemetry communication range of said local receiver, to deliver notification of the significant events to the host computer. The implantable medical device also includes a second rechargeable battery and a second communications unit powered by the second rechargeable battery. The second communications unit is capable of establishing a second communications link with said host computer over a pervasive wireless communications network, such as a cell phone network, to deliver notification of the significant events to the host computer.

Claims

1. An implantable medical device for use in a patient management system, said medical device comprising:

a sensor capable of measuring a body characteristic and generating a data signal describing the measurement;

a processor configured to analyze the data signal and configured to identify one or more significant events that warrant attention for the well-being of a patient;

a first battery, wherein the first battery is non-rechargeable and configured to power at least the sensor and the processor; and

a first communications unit configured to be powered by the first battery comprising a wireless transmitter capable of establishing a first communications link with a host computer using an external local receiver, when said first wireless transmitter is within a short-range telemetry communication range of said local receiver, to deliver at least notification of the one or more significant events to said host computer using said first communications link; and

a second battery wherein the second battery is rechargeable; and

a second communications unit powered by the second battery comprising a second wireless transmitter/receiver unit capable of establishing a second communications link with said host computer over a pervasive wireless communications network to deliver at least notification of the one or more significant events to said host computer over said second communications link.

2. The device of claim 1 wherein the pervasive wireless network is a wireless local area network or wireless wide area network.

3. The device of claim 1 wherein the first communication link is a radio frequency link.

4. The device of claim 3 further comprising a third communications unit powered by the first battery, wherein the third communications unit comprises a third transmitter/receiver unit capable of establishing an inductive third communications link with an inductive external local transmitter/receiver unit.

5. The device of claim 1 wherein the first communication unit further comprises a transceiver that includes the transmitter.

6. The device of claim 5 wherein the first communications unit wirelessly transmits information related to the data signal when interrogated by the local transceiver.

7. The device of claim 1 wherein the sensor is a cardiac sensor and the data signal is a cardiac activity signal, further comprising a therapy device for determining an appropriate electrical pulse therapy in response to a condition detected by the sensor and delivering the appropriate electrical pulse therapy to two or more implanted electrodes.

8. The device of claim 7 wherein the one or more significant events comprise one or more significant medical events that merit medical attention including any of a myocardial infarction, cardiac signals indicating an upcoming de-compensation incident, and delivery of a defibrillation shock by the implantable medical device.

9. The device of claim 7 wherein the one or more significant events comprise one or more significant device events that threaten correct operation of the implantable medical device including any of a system fault, a significant change in impedance of implanted leads, an end-of-life battery state, a reset of the device, the device being in non-therapy mode, and failure of a self-test.

10. The device of claim 1 wherein the second communications unit wirelessly transmits information related to the data signal to the host computer at regularly scheduled intervals.

11. The device of claim 1 wherein the first battery is configured to provide power to all components of the implantable medical device and the second battery is configured to provide power to only the second communications unit.

12. The device of claim 1 wherein the second battery is configured to be recharged inductively.

13. The device of claim 1 wherein the second battery is configured to be recharged acoustically.

14. A method of communication between an implantable medical device for use in a patient management system and a host computer, said method comprising the steps of:

providing an implantable medical device and a host computer, the implantable medical device comprising a sensor capable of measuring a body characteristic and generating a data signal that describes the measurement, a processor configured to analyze the data signal and configured to identify one or more significant events that warrant attention for the well-being of a patient, a first battery, wherein the first battery is non-rechargeable, and a second battery, wherein the second battery is rechargeable;

identifying an occurrence of the one or more significant events;

wirelessly transmitting notification of the occurrence of the one or more significant events by a first communication unit to an external local receiver, when said first communication unit is within a short-range telemetry communication range of said local receiver, to deliver at least said notification to the host computer;

providing power from the first battery to the sensor, processor and first communications unit; and

when said first communication unit is out of range of the local receiver, wirelessly transmitting notification of the occurrence of the one or more significant events from the implantable medical device to a host computer by a second communications unit over a pervasive wireless communications network; and

providing power from the second battery to the second communications unit.

15. The method of claim 14 wherein the sensor is a cardiac sensor and the data signal is a cardiac activity signal, wherein the one or more significant events comprise one or more significant medical events that merit medical attention including any of a myocardial infarction, cardiac signals indicating an upcoming de-compensation incident, and delivery of a defibrillation shock by the implantable medical device.

16. The method of claim 15 wherein the one or more significant events comprise one or more significant device events that threaten correct operation of the implantable medical device including any of a system fault, a significant change in impedance of leads, a reset of the device, the device being in non-therapy mode, end of life battery state, and failure of a self-test.

17. The method of claim 14, further comprising wirelessly transmitting information related to the data signal on a regular schedule by a first communication unit to the external local receiver, when said first communication unit is within a short-range telemetry communication range of said local receiver.

18. The method of claim 14, further comprising wirelessly transmitting the information related to the data signal from the sensor by the second communication unit, wherein the step of wirelessly transmitting clinical data is carried out by the second communication unit on a regular schedule.

19. The method of claim 18, further comprising:

monitoring the battery charge level of the second battery;

if the battery charge level is at or below a predefined low level, preventing the second communications unit from wirelessly transmitting clinical data to the host computer on the regular schedule, wherein the predefined low level is sufficient to allow the second communications unit to send event information to the host computer upon the detection of an adverse event.

20. An implantable medical device for use in a patient management system, said medical device comprising:

a cardiac sensor capable of measuring a cardiac characteristic and generating a cardiac activity signal that corresponds to cardiac characteristic;

a processor configured to analyze the cardiac activity signal and configured to identify one or more significant events that warrant attention for the well-being of a patient;

a therapy device for determining an appropriate electrical pulse therapy in response to a condition detected by the cardiac sensor and delivering the appropriate electrical pulse therapy to two or more implanted electrodes;

a first battery configured to power at least the cardiac sensor, the therapy device and the processor, wherein the first battery is non-rechargeable; and

a first communications unit configured to be powered by the first battery comprising a wireless transmitter/receiver capable of establishing a first communications link with a host computer using an external local transceiver, when said first wireless transmitter/receiver unit is within a short-range telemetry communication range of said local transceiver, to deliver at least the cardiac activity signal and notification of the one or more significant events to said host computer using said first communications link; and

a second battery, wherein the second battery is rechargeable;

a second communications unit powered by the second battery comprising a second wireless transmitter/receiver unit capable of establishing a second communications link with said host computer over a wireless telephone network to deliver at least notification of the one or more significant events to said host computer over said second communications link; and

a third communications unit powered by the first battery, wherein the third communications unit comprises a third transmitter/receiver unit capable of establishing an inductive third communications link with an inductive external local transmitter/receiver unit.