Cardiac simulation system having multiple stimulators for anti-arrhythmia therapy

• US 6,141,588 A
• Filed: 07/24/1998
• Issued: 10/31/2000
• Est. Priority Date: 07/24/1998
• Status: Expired due to Term

• Current Assignee: Intermedics Incorporated
• Original Assignee: Intermedics Incorporated
• Inventors: Cox, Timothy J., Rosborough, John P.
• Primary Examiner(s): Layno, Carl H.
• Application Number:
  US09/122,398
• Time in Patent Office: 830 Days
• Field of Search: 607/9, 607/33, 607/36, 607/37, 128/903
• US Class Current: 607/9
• CPC Class Codes: A61N 1/3622 comprising two or more electrodes co-operating with different heart regions
• 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 1/37211 Means for communicating with stimulators
• CPC Class Codes: A61N 1/37217 characterised by the communication link, e.g. acoustic or tactile
• CPC Class Codes: A61N 1/37288 Communication to several implantable medical devices within one patient
• CPC Class Codes: A61N 1/375 Constructional arrangements, e.g. casings
• CPC Class Codes: A61N 1/37512 Pacemakers
• CPC Class Codes: Y10S 128/903 Radio telemetry

Abstract

A medical system comprising a control device (referred to as a "planet") and a plurality of sensing and stimulating devices (referred to as "satellites") is disclosed. The satellites are relatively small devices that can be thoracoscopically attached to an exterior surface of the heart. The planet can be implanted if desired or, alternatively, externally retained. The planet is capable of wirelessly communicating (i.e., without a direct electrical connection) to each satellite. The planet individually commands each satellite to deliver pacing energy to the heart. Additionally, each satellite is capable of determining when a sense event has occurred at the site of that satellite and transmitting an encoded signal to the planet indicating that a sense event has occurred, along with an identifying code indicating to the planet which satellite detected the sense event. The planet processes the encoded signals received from the network of satellites, assigns time values to each satellite when that satellite detects a sense event, compares the time values to a template of normal values, and determines if an arrhythmia has occurred if the time values do not match the template. Further, the planet selects and implements an appropriate pacing protocol to terminate the arrhythmia. The satellites derive their needed power from signals received from the planet via the wireless communication path.

Claims

1. An implantable medical device for attachment to human tissue, comprising:

a plurality of electrodes for connection to the tissue;

a communications device for receiving signals and energy via a wireless communication path from a control device;

a stimulus storage device coupled to said communications device and said electrodes for receiving electrical energy from said communications device to be stored and delivered to the tissue through the electrodes;

a rectifier disposed between said communications device and said stimulus storage device for rectifying said signals received from said control device;

a regulator disposed between said rectifier and said stimulus storage device for regulating the rectified signal from said rectifier; and

a receiver data decoder/encoder having a data encoder for producing encoded wireless communication signals identifying said implantable medical device and for conveying data.

2. The implantable medical device of claim 1 wherein said communications device includes an antenna.

3. The implantable medical device of claim 1 wherein all of the electrical energy needed to operate the medical device is obtained from the wireless communication signals received by the communications device.

4. The implantable medical device of claim 1 wherein said receiver data decoder/encoder further has a data decoder for decoding the wireless communication signals received by the communications device.

5. The implantable medical device of claim 4 wherein said receiver data decoder/encoder commands said stimulus storage device to deliver said stored electrical energy to said electrodes upon decoding a signal from the communications device indicating that at least part of the stored energy should be delivered to the electrodes.

6. The implantable medical device of claim 1 wherein said electrodes include a barbed projection for attaching said medical device to said tissue.

7. The implantable medical device of claim 1 wherein said electrodes include a spiral projection for attaching said medical device to said tissue.

8. The implantable medical device of claim 1 wherein said electrodes include a means for attaching said medical device to said tissue.

9. The implantable medical device of claim 1 wherein said medical device is approximately circular in cross section with a diameter of less than approximately 8 millimeters.

10. An implantable medical device for attachment to human tissue, comprising:

a plurality of electrodes for connection to the tissue;

a communications device for receiving signals and energy via a wireless communication path from a control device, wherein said communications device includes a transducer to convert non-electromagnetic energy to electrical energy;

a stimulus storage device coupled to said communications device and said electrodes for receiving electrical energy from said communications device to be stored and delivered to the tissue through the electrodes;

a rectifier disposed between said communications device and said stimulus storage device for rectifying said signals received from said control device; and

a regulator disposed between said rectifier and said stimulus storage device for regulating the rectified signal from said rectifier.

11. An implantable medical device for attachment to human tissue, comprising:

a plurality of electrodes for connection to the tissue;

a communications device for receiving signals and energy via a wireless communication path from a control device, wherein said communications device includes an antenna and wherein said antenna includes a direction of highest energy radiation per unit solid angle that is not co-axial with a longitudinal axis of the antenna;

a stimulus storage device coupled to said communications device and said electrodes for receiving electrical energy from said communications device to be stored and delivered to the tissue through the electrodes;

a rectifier disposed between said communications device and said stimulus storage device for rectifying said signals received from said control device; and

a regulator disposed between said rectifier and said stimulus storage device for regulating the rectified signal from said rectifier.

12. An implantable medical device for attachment to human tissue, comprising:

a plurality of electrodes for connection to the tissue;

a communications device for receiving signals and energy via a wireless communication path from a control device;

a stimulus storage device coupled to said communications device and said electrodes for receiving electrical energy from said communications device to be stored and delivered to the tissue through the electrodes;

a rectifier disposed between said communications device and said stimulus storage device for rectifying said signals received from said control device;

a regulator disposed between said rectifier and said stimulus storage device for regulating the rectified signal from said rectifier; and

a rechargeable battery, wherein at least part of the electrical energy received by said communications device is delivered to said battery.

13. An implantable medical device for attachment to human tissue, comprising:

a plurality of electrodes for connection to the tissue;

a communications device for receiving signals and energy via a wireless communication path from a control device;

a stimulus storage device coupled to said communications device and said electrodes for receiving electrical energy from said communications device to be stored and delivered to the tissue through the electrodes;

a rectifier disposed between said communications device and said stimulus storage device for rectifying said signals received from said control device;

a regulator disposed between said rectifier and said stimulus storage device for regulating the rectified signal from said rectifier; and

a sense amplifier and comparator coupled to said electrodes for amplifying electrical signals generated by said tissue and comparing said amplified signal to a reference signal to verify that a sense event has occurred.

14. The implantable medical device of claim 13 further including a sense event state interface coupled to said amplifier and comparator and a receiver data decoder/encoder to provide an identifying signal indicating the occurrence of a sense event.

15. The implantable medical device of claim 14 wherein said communications device receives an indication from said sense event state interface of a sense event and said communications device transmits via a wireless communications path to said processing device a signal indicating the occurrence of a sense event.

16. The implantable medical device of claim 13 further including a means for communicating the occurrence of said sense event via a wireless communication path to a processing device.

17. A planet medical device for controlling a plurality of satellite implantable medical devices, comprising:

a processor for interpreting signals received from the plurality of satellite devices;

a memory device coupled to said processor;

a communications device coupled to said processor for receiving signals from and transmitting signals to said plurality of satellite devices;

a battery for providing electrical power to said processor, memory device, communications device, and said satellite devices; and

a clock providing a periodic timing signal to said processor for assigning time values to sense events reported by each satellite device.

18. The planet device of claim 17 further including a receiver data decoder disposed between said communications device and said processor for decoding signals received from said satellites via said communications device and providing said decoded signals to said processor.

19. The planet device of claim 18 wherein said receiver data decoder is capable of decoding signals from said satellites as sense events.

20. The planet device of claim 19 further including a counter for counting cycles of said periodic timing signal and providing a count value to said processor.

21. The planet device of claim 20 wherein said processor resets or latches the output of said counter upon receipt of a wireless sense event signal from a planet.

22. The planet device of claim 20 wherein said processor latches an output signal from said counter upon receipt of a wireless sense event signal from a planet.

23. The planet device of claim 21 wherein said planet that causes said processor to reset said counter is an initial satellite and said processor assigns a count value to each of the other satellites upon receipt of a sense event signal from the other satellites.

24. The planet device of claim 23 wherein said processor compares said assigned count values to a template of normal count values to determine if an anomalous condition has occurred.

25. The planet device of claim 24 wherein said planet device is adapted to be used in conjunction with satellites attached to a human heart and said template of normal count values represents the count values for the patient during a normal cardiac rhythm.

26. The planet device of claim 17 wherein said planet device is implantable into a human body.

27. A planet medical device for controlling a plurality of satellite devices, comprising:

a processor for initiating timing signals to be communicated to said satellite devices;

a memory device coupled to said processor;

a communications device coupled to said processor for receiving signals from and transmitting signals to said plurality of satellite devices; and

a battery for providing electrical power to said processor, memory device, communications device, and said satellite devices.

28. A medical system for monitoring and stimulating the heart to beat, comprising:

a planet control device, including;

a processor;

a memory device coupled to said processor;

a planet communications device coupled to said processor for receiving and transmitting signals using a wireless communications technique; and

a battery for providing electrical power to said processor, memory device, and communications device; and

a plurality of satellite sensing and stimulating devices, each satellite including;

a plurality of electrodes for connection to the heart;

a satellite communications device for receiving signals from and transmitting signals to said communications device in said planet control device via said wireless communication technique;

a rectifier coupled to said satellite communications device to derive operational electrical power needed by the satellite from the signals received by said satellite communications device wirelessly transmitted by said planet communications device; and

a regulator coupled to said rectifier for regulating the rectified signal from said rectifier.

29. The medical system of claim 28 wherein the electrodes of said satellites include projections to permit the satellites to be attached to an exterior surface of the heart.

30. The medical system of claim 28 wherein said satellites include a stimulus storage device disposed between said rectifier and said electrodes for storing electrical charge to be subsequently delivered to the heart via the electrodes to stimulate the depolarization of cardiac tissue.

31. The medical system of claim 28 wherein said satellites further include a sense amplifier and comparator coupled to said electrodes and said satellite communications device to process signals detected by said electrodes, compare said signals with a reference signal and provide an indicator signal to said communications device that a sense event has occurred.

32. The medical system of claim 31 wherein said satellite includes a receiver data decoder/encoder having a data encoder and disposed between said sense amplifier and comparator and said satellite communications device to generate an encoded signal to be wireless transmitted to said planet communications device via said satellite communications device to indicate that a sense event has occurred.

33. The medical system of claim 32 wherein said receiver data decoder/encoder also encodes a satellite identifier into said encoded signal.

34. The medical system of claim 33 wherein said planet also includes a clock for providing a periodic timing signal and a counter for receiving said timing signal and producing an output count value indicative of the number of cycles of said timing signal counted by said counter.

35. The medical system of claim 34 wherein said processor reads said count values from said counter and assigns said count values to a satellite upon receipt of an encoded signal from that satellite that a sense event has occurred.

36. The medical system of claim 35 wherein said processor resets or latches the output of said counter upon receipt of an encoded signal from a predetermined satellite that a sense event has occurred.

37. A method for implanting and initializing an implantable leadless medical system, comprising:

attaching a plurality of satellite devices to the heart;

communicating the number of implanted satellite devices to a central control unit;

communicating the identity of a first satellite device that will first detect a sense event during each cardiac cycle to the central control unit; and

storing the identity of said first satellite device in memory and said central control unit.

38. The method of claim 37 further including establishing a communication link between said central control unit and each of said satellite devices to ensure each satellite device is operational.

39. The method of claim 37 further including detecting sense events by the satellite devices while the patient is experiencing normal cardiac rhythm and transmitting signals that indicate the occurrence of sense events to the central control device.

40. The method of claim 39 further including resetting or latching the output of a counter upon receipt of a signal indicating the occurrence of a sense event from the first satellite device.

41. The method of claim 40 further including assigning a count value to all other satellite devices that transmit signals indicating the occurrence of a sense event.

42. The method of claim 41 wherein said assigned count values comprise a template and storing said assigned count values in memory and said central control device.

43. A method for pacing and sensing a human heart using an apparatus that includes a plurality of implantable satellites attached to the heart and a planet control device that communicates with said satellites via a wireless transmission link, said method comprising:

receiving signals indicating the occurrence of sense events from said satellites;

assigning time values to said satellites upon receipt by said planet of said sense event signals;

comparing said time values to a template of time values;

determining that an arrhythmia has occurred if said time values do not match said template within a predetermined tolerance; and

communicating the times at which one or more satellites should stimulate cardiac tissue to correct the arrhythmia.