Telemetry system for an implantable cardiac device

• US 5,342,408 A
• Filed: 01/07/1993
• Issued: 08/30/1994
• Est. Priority Date: 01/07/1993
• Status: Expired due to Term

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: InControl, Inc. (Daikin Industries Ltd)
• Inventors: deCoriolis, Paul E., Bocek, Joseph M., Siegman, Craig S.
• Primary Examiner(s): Howell, Kyle L.
• Assistant Examiner(s): MANUEL, GEORGE C
• Application Number:
  US08/001,330
• Time in Patent Office: 600 Days
• Field of Search: 607/30, 607/31, 607/32, 607/27, 607/17
• US Class Current: 607/32
• CPC Class Codes: A61N 1/37254 Pacemaker or defibrillator security, e.g. to prevent or inhibit programming alterations by hackers or unauthorised individuals
• CPC Class Codes: A61N 1/37276 characterised by means for reducing power consumption during telemetry

Abstract

A telemetry system and method of monitoring cardiac activity or providing therapy to the heart for an implantable cardiac device. The system includes a receiver and a transmitter in an external programmer and a receiver section and transmitter section in the cardiac device. The receiver section and the transmitter section of the cardiac device generally remain in a de-energized state. The receiver section is energized at spaced apart time intervals to detect an initiation signal transmitted by the external programmer. If the initiation signal is detected, the receiver section and the transmitter section of the cardiac device are fully activated. The external programmer includes a signal strength indicating means for providing an indication of received signal strength which the user can use to position the receiver and transmitter in the external programmer for optimum received signal strength. An antenna is disposed in the header of the implanted device to facilitate communication at high speed.

Claims

1. A cardiac device which monitors activity of a human heart, or provides therapy to the human heart, or both, said cardiac device being implantable beneath the skin of a patient and comprising:

at least one electrode for sensing activity of the heart or providing therapy to the heart;

circuit means coupled to said at least one electrode for providing therapy or monitoring the activity of the heart sensed by said at least one electrode, said circuit means including data generating means for generating data indicative of said monitored activity or therapeutic activity in accordance with received command transmissions; and

telemetry means for communicating with a non-implanted external receiver and transmitter, said telemetry means including

receiving means for receiving said command transmissions from said non-implanted external transmitter, said command transmissions conforming to a first protocol and said command transmissions being selectively transmitted at two or more rates in accordance with said first protocol; and

transmitting means for transmitting information including said data to said non-implanted external receiver in accordance with a second protocol, said information transmissions being selectively transmitted at one or more rates in accordance with said second protocol,

said first protocol being different from said second protocol.

2. A cardiac device as defined in claim 1 further including memory means coupled to said circuit means for storing said data and direct memory access means coupled to said memory means and said transmitting means for conveying said data to said transmitting means.

3. A cardiac device as defined in claim 2 wherein said direct memory access means further conveys said command transmissions to said memory means.

4. A cardiac device as defined in claim 1 further including a single antenna coupled to said receiving means and to said transmitting means for both receiving said command transmissions and transmitting said information.

5. A system which monitors activity of a human heart, or provides therapy to the human heart, or both, said system comprising:

an implantable cardiac device, said implantable cardiac device including at least one electrode for sensing activity of the heart, or providing therapy to the heart, said implantable cardiac device further including circuit means coupled to said at least one electrode for providing therapy or monitoring the activity of the heart sensed by said at least one electrode, said circuit means including data generating means for generating data indicative of said monitored activity or therapeutic activity in accordance with received command transmissions;

a non-implantable external device; and

telemetry means for establishing communication between said non-implantable external device and said implantable cardiac device, said telemetry means including

a receiver within said non-implantable external device;

a transmitter within said non-implantable external device;

receiving means within said cardiac device for receiving said command transmissions from said transmitter, said command transmissions conforming to a first protocol and said command transmissions being selectively transmitted at two or more rates in accordance with said first protocol; and

transmitting means within said cardiac device for transmitting information including said data to said receiver in accordance with a second protocol, said information being selectively transmitted at one or more rates in accordance with said second protocol;

said first protocol being different from said second protocol;

said transmitter including command transmitting means for selectively transmitting said command transmissions at a first rate or at a second rate in accordance with said first protocol.

6. A system as defined in claim 5 wherein said transmitter transmits said command transmissions at said first rate before a communications link is established between said transmitting means and said receiver, and said transmitter transmits said command transmissions at said second rate after said communications link is established.

7. A system as defined in claim 5 wherein, responsive to said first protocol, said transmitter within said non-implantable external device modulates a carrier signal amplitude in accordance with said command transmissions.

8. A system as defined in claim 5 wherein, responsive to said first protocol, said transmitter within said non-implantable external device pulse width modulates a carrier signal in accordance with said command transmissions.

9. A system as defined in claim 5 wherein said receiving means includes verification means for verifying accurate receipt of said command transmissions.

10. A system as defined in claim 9 wherein said telemetry means further comprises a command decoder responsive to said verification means for decoding said command transmissions.

11. A system as defined in claim 9 wherein said command transmissions include one or more inbound frames, said verification means being responsive to said one or more inbound frames for verifying accurate receipt of said command transmissions.

12. A system as defined in claim 11 wherein each inbound frame of said one or more inbound frames includes a leading flag, an inbound frame check, a trailing flag and a control field, said control field including a command for controlling said cardiac device.

13. A system as defined in claim 12 wherein said inbound frame check includes a cyclic redundancy check code.

14. A system as defined in claim 11 wherein said command transmissions are transmitted at a first rate before a communications link is established between said telemetry means and said non-implanted external receiver and said command transmissions are transmitted at a second rate after said communications link is established and wherein each said inbound frame transmitted at said second rate further includes a data field.

15. A system as defined in claim 5 wherein, responsive to said second protocol said transmitting means modulates a carrier signal phase shift in accordance with said data.

16. A system as defined in claim 15 wherein, responsive to said second protocol, said transmitting means modulates said carrier signal using absolute phase shift keying.

17. A system as defined in claim 5 wherein said transmitter within said non-implantable external device includes means for transmitting an initiation command transmission and wherein said telemetry means is responsive to said initiation command transmission for fully energizing said receiving means and said transmitting means of said telemetry means.

18. A system as defined in claim 17 wherein said initiation command transmission comprises a predetermined bit pattern.

19. A system as defined in claim 18 wherein said command transmissions include a preamble, said preamble and said initiation command transmission being different.

20. A system as defined in claim 18 wherein said telemetry means further includes a command decoder and wakeup detect means responsive to said predetermined bit pattern for activating said command decoder to decode said command transmissions.

21. A system as defined in claim 5 wherein said receiver within said non-implantable external device includes verification means for verifying accurate transmission of said information,

22. A system as defined in claim 21 wherein said information includes one or more frames,

23. A system as defined in claim 22 wherein each frame of said one or more frames includes a preamble and a postamble.

24. A system as defined in claim 23 wherein said preamble includes means for determining the beginning of said each frame and a frame count and said postamble includes a control field, a frame check and means for marking the end of said each frame,

25. A system as defined in claim 23 wherein said receiver within said non-implantable external device includes means for uniquely identifying each frame of said one or more frames.

26. A system as defined in claim 5 wherein said telemetry means further includes reset means for initializing said cardiac device to a predetermined state, said reset means operating independently of said circuit means.

27. A system as defined in claim 26 wherein said reset means is responsive to a reset command transmitted from said transmitter within said non-implantable external device for initializing said cardiac device to said predetermined state.

28. A cardiac device which monitors activity of a human heart, or provides therapy to a human heart, or both, said cardiac device being fully implantable beneath the skin of a patient and comprising:

at least one electrode for sensing activity of the heart or providing therapy to the heart;

circuit means coupled to said at least one electrode for providing therapy or monitoring activity of the heart sensed by said at least one electrode in accordance with received command transmissions transmitted from a non-implanted transmitter external to the skin of said patient;

receiving means for receiving said command transmissions from said non-implanted transmitter; and

activation means for enabling said receiving means to receive said command transmissions at intervals in time of controlled duration separated by intervals in time during which said activation means disables said receiving means from receiving said command transmissions.

29. A system including a cardiac device which monitors activity of a human heart, or provides therapy to a human heart, or both, said cardiac device being fully implantable beneath the skin of a patient, the system comprising;

a non-implantable transmitter and receiver external to the skin of a patient;

at least one electrode for sensing activity of the heart or providing therapy to the heart;

circuit means within said cardiac device coupled to said at least one electrode for providing therapy or monitoring activity of the heart sensed by said at least one electrode in accordance with received command transmissions transmitted from said non-implantable transmitter, said circuit means generating data indicative of monitored activity of the heart;

receiving means within said cardiac device for receiving

said command transmissions from said non-implantable transmitter;

transmitting means within said cardiac device for transmitting information including said data to said non-implantable receiver responsive to said receiving means receiving an initiation command from said non-implantable transmitter; and

activation means within said cardiac device for enabling said receiving means to receive said command transmissions at intervals in time of controlled duration separated by intervals in time during which said activation means disables said receiving means from receiving said command transmissions.

30. A system as defined in claim 29 further including a single antenna coupled to said receiving means and to said transmitting means for both receiving said command transmissions and transmitting said information.

31. A system as defined in claim 29 wherein said receiving means includes a receive amplifier, said activation means enabling said receive amplifier to detect said initiation command from said non-implanted transmitter during a predetermined time period during each interval of said intervals in time of controlled duration.

32. A system as defined in claim 31 wherein said activation means enables said transmitting means and said transmitting means transmits a response code to said non-implantable receiver in response to said receive amplifier detecting said initiation command.

33. A system as defined in claim 32 wherein said response code provides confirmation to said non-implanted receiver that said initiation command was received by said cardiac device.

34. A system as defined in claim 32 wherein said receiving means and said transmitting means are de-energized when not enabled.

35. A system as defined in claim 29 further including reset means for initializing said cardiac device to a predetermined state, said reset means operating independently of said circuit means.

36. A system as defined in claim 35 wherein said reset means is responsive to a reset command transmitted from said non-implanted transmitter.

37. A cardiac monitoring or therapeutic system for monitoring activity of a human heart or providing therapy or both, for a patient, said system comprising:

a cardiac device fully implantable beneath the skin of the patient for monitoring activity of the heart or providing therapy, or both, in accordance with received program command transmissions transmitted from external to the skin of said patient; and

telemetry means including receiving means within said cardiac device for receiving said program command transmissions, transmitting means within said cardiac device for transmitting information including locating signals, and a movable programming unit including external transmitting means for transmitting said program command transmissions, external receiving means for receiving said information and signal strength indicating means for indicating a received strength of said locating signals.

38. A cardiac system as defined in claim 37 wherein said telemetry means further includes activation means for enabling said receiving means to receive said command transmissions at intervals in time of controlled duration, separated by intervals in time during which reception does not occur.

39. A cardiac system as defined in claim 38 wherein said receiving means and said transmitting means are in a quiescent state until said receiving means receives an initiation command from said external transmitting means.

40. A cardiac system as defined in claim 39 wherein said activation means enables said receiving means to sense said initiation command at said intervals in time of controlled duration and said transmitting means transmits a response code responsive to said receiving means receiving said initiation command.

41. A cardiac system as defined in claim 40 wherein said signal strength indicating means provides an indication of received signal strength responsive to said external receiving means receiving said response code or other command transmissions from said cardiac device.

42. A cardiac device as defined in claim 40 wherein said transmitting means transmits said response code a predetermined time after said receiving means receives said initiation command.

43. A cardiac device for monitoring the physiology of the human heart and delivering therapy to the heart, or both, said device being fully implantable beneath the skin of a patient and comprising:

a hermetically sealed enclosure, said enclosure including a perimeter, and an electrically insulating header sealingly engaging a portion of said perimeter;

at least one electrode for sensing activity of the heart;

circuit means within said enclosure and coupled to said at least one electrode for providing therapy or monitoring the activity of the heart sensed by said at least one electrode and for generating data indicative of the monitored activity of the heart responsive to command transmissions received from an external programmer; and

one or more antennas disposed within said header for transmitting said data to a non-implanted external receiver and for receiving said command transmissions.

44. A method of communicating in a cardiac monitoring or therapeutic device, said method comprising the steps of:

sensing activity of the heart or providing therapy to the heart;

generating data indicative of said activity in accordance with received command transmissions;

providing a receiver and receiving from a non-implanted transmitter said command transmissions, said command transmissions conforming to a first protocol; and

transmitting information including said data to a non-implanted receiver in accordance with a second protocol, said second protocol being different from said first protocol.

45. A method as defined in claim 44 including the further step of establishing a communications link between said non-implanted transmitter and said receiver and transmitting said command transmissions at a first rate before said communications link is established and transmitting said command transmissions at a second rate after said communications link is established.

46. A method as defined in claim 44 wherein said first protocol includes the step of modulating a carrier signal amplitude in accordance with said command transmissions.

47. A method as defined in claim 44 wherein said first protocol includes the step of modulating the pulse width of a carrier signal in accordance with said command transmissions.

48. A method as defined in claim 44 including the further step of verifying accurate receipt of said command transmissions.

49. A method as defined in claim 48 including the further step of decoding said command transmissions.

50. A method as defined in claim 49 wherein said second protocol includes the step of providing said command transmission with one or more inbound frames including a leading flag, an inbound frame check, a trailing flag and a control field, said control field including a command for controlling said cardiac device.

51. A method as defined in claim 44 including the further step of modulating a carrier signal phase shift in accordance with said data.

52. A method as defined in claim 51 wherein said modulating step includes absolute phase shift keying.

53. A method as defined in claim 44 including the further steps of receiving an initiation command transmission and fully energizing said receiver in response to said initiation command transmission.

54. A method as defined in claim 53 wherein said initiation command transmission includes a predetermined bit pattern.

55. A method as defined in claim 53 including the further step of providing a command decoder and wakeup detect means responsive to said predetermined bit pattern for activating said command decoder to decode said command transmissions.

56. A method as defined in claim 44 including the further step of providing a single antenna for both receiving said command transmissions and transmitting said information.

57. A method of communicating in a cardiac monitoring or therapeutic device, said method comprising the steps of:

sensing activity of the heart or providing therapy to the heart;

providing therapy to the heart or monitoring the activity of the heart in accordance with received command transmissions transmitted from a non-implanted transmitter and generating data indicative of said monitored activity;

providing a receiver to receive said command transmissions from said non-implanted transmitter; and

enabling said receiver to receive said command transmissions at intervals in time of controlled duration, separated by intervals in time during which said receiver is disabled from receiving said command transmissions.

58. A method as defined in claim 57 including the further step of providing a transmitter to transmit information including said data to a non-implanted receiver.

59. A method as defined in claim 58 including the further steps of detecting an initiation transmission command transmitted from said non-implanted transmitter and enabling said transmitter to transmit a response code to said non-implanted receiver.

60. A method as defined in claim 59 including the further step of de-energizing said transmitter and said receiver when said transmitter and said receiver are not enabled.

61. A method for monitoring activity of a human heart or providing therapy to the heart of a patient comprising the steps of:

providing a receiver for receiving program transmissions transmitted from external to the skin of the patient;

providing therapy or monitoring activity of the heart responsive to said program transmissions;

transmitting information including locating signals; and

providing a movable programming unit for transmitting said command transmissions, receiving said information and indicating a received signal strength of said locating signals.

62. A method as defined in claim 61 including the further step of enabling said receiver to receive said command transmissions at intervals in time of controlled duration, separated by intervals in time during which reception does not occur.

63. A method as defined in claim 61 including the further steps of transmitting an initiation command from said movable programming unit to said receiver and transmitting a response code to said movable programming unit.