Broadcast audible sound communication from an implantable medical device

• US 6,450,172 B1
• Filed: 01/25/2000
• Issued: 09/17/2002
• Est. Priority Date: 04/29/1998
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Greeninger, Daniel R., Thompson, David L., Hartlaub, Jerome T.
• Primary Examiner(s): Lacyk, John P.
• Application Number:
  US09/491,398
• Time in Patent Office: 966 Days
• Field of Search: 128/899, 128/904, 607/30-32, 607/59-60
• US Class Current: 128/899
• CPC Class Codes: A61N 1/37217 characterised by the communication link, e.g. acoustic or tactile
• CPC Class Codes: A61N 1/37223 Circuits for electromagnetic coupling
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 1/37264 Changing the program; Upgrading firmware
• CPC Class Codes: A61N 1/3727 characterised by the modulation technique

Abstract

Methods and apparatus for communication of implantable medical device (IMD) information, including interrogation of programmed parameter values, operating modes and conditions of operation, confirmation of programmed changes thereof, interrogation of data stored in the IMD, and patient warnings or other messages by RF transmission of audible sounds generated by the IMD are disclosed. The IMD includes an RF transmitter that broadcasts or transmits audible sounds including voiced statements or musical tones stored in analog memory correlated to a programming or interrogation operating algorithm or to a warning trigger event. The broadcast radio signal is received, and the audible sounds are demodulated and reproduced by a radio receiver as voiced statements or musical tones that convey human understandable messages comprising IMD information generated during programming and interrogation sessions and warnings or status messages to the patient at other times.

Claims

1. A communication system for communicating implantable medical device information from an implantable medical device through a patient'"'"'s body to a radio receiver external to the patient'"'"'s body comprising:

a storage and playback circuit having a plurality of audio drive signals recorded as human understandable voice statements corresponding to medical device operational characteristics, the audio drive signals being recorded at a corresponding plurality of addressable storage locations;

a radio frequency transmitter to broadcast radio frequency signals modulated by audio drive signals retrieved from the storage and playback circuit, the modulated broadcast radio frequency signals being broadcast outside the patient'"'"'s body;

an address generation circuit to select and apply an address to the storage and playback circuit to retrieve a particular audio drive signal to be provided to the radio frequency transmitter;

a timing control circuit coupled to the address generation circuit to generate commands for the address generation circuit to identify a particular audio drive signal to be retrieved from the storage and playback; and

a radio receiver located outside the patient'"'"'s body to receive and demodulate the modulated broadcast radio frequency signals to reproduce the human understandable voice statement.

2. The system of claim 1, wherein the medical device operational characteristics is selected from a group comprising:

medical device manufacturer;

medical device identification;

patient identification;

date of implantation;

date of last interrogation;

stored physiologic data;

battery condition;

real time device operations;

current programmed operating modes;

current programmed operating parameter values;

depletion of a substance reservoir;

an impending device operation; and

a detected condition of the patient.

3. The system of claim 1, wherein:

the storage and playback circuit stores an audio drive signal correlated to a battery power level of the implantable medical device; and

the address generation circuit selects and applies an address to the storage and playback circuit to retrieve the audio drive signal related to battery power level of the implantable medical device and applying the retrieved audio drive signal to the radio frequency transmitter to cause the radio frequency transmitter to broadcast a modulated radio frequency signal to the radio receiver indicative of the battery power level of the implantable medical device.

4. The system of claim 1, wherein:

the storage and playback circuit stores an audio drive signal correlated to a warning toe patient of a determined onset of a malignant tachyarrhythmia; and

the address generation circuit selects and applies an address to the storage and playback circuit to retrieve the audio drive signal related to a warning to the patient of the determined onset of a malignant tachyarrhythmia and applying the retrieved audio drive signal to the radio frequency transmitter to cause the radio frequency transmitter to broadcast a modulated radio frequency signal to the radio receiver indicative of a warning to the patient of the determined onset of a malignant tachyarrhythmia.

5. The system of claim 1, wherein:

the storage and playback circuit stores an audio drive signal correlated to a determination by the implantable medical device of an onset of a malignant tachyarrhythmia and impending delivery of a cardioversion/defibrillation shock therapy by the implantable medical device; and

the address generation circuit selects and applies an address to the storage and playback circuit to retrieve an audio drive signal related to the determined malignant condition and applying the retrieved audio drive signal to the radio frequency transmitter to cause the radio frequency transmitter to broadcast a modulated radio frequency signal to the radio receiver indicative of the malignant tachyarrhythmia condition and impending delivery of a cardioversion/defibrillation shock therapy by the implantable medical device.

6. The system of claim 1, wherein:

the storage and playback circuit stores an audio drive signal correlated to delivery of a pacing pulse by the implantable medical device; and

the timing control circuit in response to delivery of a pacing pulse commands the address generation circuit to select and apply an address to the storage and playback circuit to retrieve the pacing pulse audio drive signal and apply the retrieved audio drive signal to the radio frequency transmitter to cause the radio frequency transmitter to broadcast a modulated radio frequency signal to the radio receiver indicative of the delivery of the pacing pulse by the implantable medical device.

7. The system of claim 6, wherein:

the storage and playback circuit stores an audio drive signal correlated to a cardiac sense event signal registered by the implantable medical device; and

the timing control circuit in response to a cardiac sense event signal commands the address generation circuit to select and apply an address to the storage and playback circuit to retrieve the cardiac sense event audio drive signal and apply the retrieved audio drive signal to the radio frequency transmitter to cause the radio frequency transmitter to broadcast a modulated radio frequency signal to the radio receiver indicative of a cardiac sense event signal being registered by the implantable medical device.

8. The system of claim 1, wherein:

the storage and playback circuit stores an audio drive signal correlated to delivery of a substance from a reservoir in the implantable medical device to the patient'"'"'s body tissue; and

the address generation circuit in response to delivery of a substance from a reservoir in the implantable medical device selects and applies an address to the storage and playback circuit to retrieve the substance delivery audio drive signal and apply the retrieved audio drive signal to the radio frequency transmitter to cause the radio frequency transmitter to broadcast a modulated radio frequency signal to the radio receiver indicative of the delivery of a substance from a reservoir in the implantable medical device to the patient'"'"'s body tissue.

9. The system of claim 8, wherein the substance delivery reservoir of the plantable medical device has a defined capacity and its content is monitored for amount of remaining substance and wherein:

the storage and playback circuit stores an audio drive signifying depletion of the substance in the reservoir; and

the address generation circuit in response to depletion of the substance in the reservoir of the implantable medical device selects and applies an address to the storage and playback circuit to retrieve the substance depletion audio drive signal and apply the retrieved audio drive signal to the radio frequency transmitter to cause the radio frequency transmitter to broadcast a modulated radio frequency signal to the radio receiver indicative of the depletion of the substance in the reservoir.

10. A method for communicating implantable medical device information from an implantable medical device through a patient'"'"'s body to a radio receiver external to the patient'"'"'s body comprising the steps of:

storing one or more audio drive signals each comprising a human understandable voiced statement signifying implantable medical device information within the implantable medical device; and

selecting one or more stored audio drive signal for broadcast;

broadcasting a radio frequency signal modulated by each selected audio drive signal the broadcast radio frequency signal being received and demodulated by the radio receiver to produce a human understandable voiced statement or the other audible sound; and

receiving, demodulating and reproducing the human understandable voiced statement through the radio receiver.

11. The system of claim 10, wherein the medical device information is selected from the group that further comprises:

a medical device manufacturer;

medical device identification;

patient identification;

date of implantation;

date of last interrogation;

stored physiologic data;

battery condition;

real time device operations;

current programmed operating modes;

current programmed operating parameter values;

depletion of a substance reservoir;

an impending device operation; and

a detected condition of the patient.

12. The method of claim 10, for broadcasting a message from an implantable medical device through a patient'"'"'s body to the radio receiver external to the patient'"'"'s body further comprising the step of:

monitoring a condition or state or impending operation or consummated operation of the implantable medical device or a condition or state of the patient and providing a message trigger signal in response thereto; and

wherein the selecting step further comprises the step of;

selecting a stored audio drive signal of implantable medical device information in compliance with the message trigger signal.

13. The method of claim 12, wherein the medical device information stored as audio drive signals at specified memory addresses are selected from the group that further comprises:

physiologic patient condition;

battery condition;

depletion of a substance reservoir

an impending device operation; and

a consummated device operation,

which when reproduced by the radio receiver constitute human understandable voiced statements or audible sounds.

14. The method of claim 12, wherein the implantable medical device is powered by a battery that depletes with consumption of power by the implantable medical device and wherein:

the storing step further comprises storing an audio drive signal capable of being reproduced as the human understandable voiced statement or sound conveying battery power level; and

the monitoring step further comprises monitoring the power level of the battery and for providing a message trigger signal related to power level,

whereby the radio frequency transmitter broadcasts a modulated radio frequency signal capable of being detected and demodulated by the radio receiver to produce the human understandable voiced statement or the other audible sound warning indicative of the battery power level.

15. The method of claim 12, wherein:

the storing step further comprises storing an audio drive signal that is reproducible as the human understandable voiced statement conveying a warning to the patient of the determined onset of a malignant physiologic condition; and

the monitoring step further comprises the steps of;

monitoring the physiologic condition of the patient,

determining the onset of the malignant condition of the patient from the monitored physiologic condition or state of the patient; and

providing a message trigger signal,

whereby the audio drive signal related to the determined malignant condition is broadcast as a modulated radio frequency signal that is detected and demodulated by the radio receiver to produce the human understandable voiced statement warning of the malignant condition.

16. The method of claim 15, wherein the malignant condition is a tachyarrhythmia of the patient'"'"'s heart.

17. The method of claim 12, wherein:

the storing step further comprises storing an audio drive signal that is reproducible as the human understandable voiced statement conveying a warning to the patient of the impending delivery of a therapy by the implantable medical device; and

the monitoring step further comprises the steps of;

monitoring the impending delivery of a therapy; and

providing a message trigger signal,

whereby the audio drive signal related to the impending delivery of the therapy is broadcast as a modulated radio frequency signal that is detected and demodulated by the radio receiver to produce the human understandable voiced statement warning of the impending delivery of the therapy to the patient.

18. The method of claim 17, wherein the therapy to be delivered is a cardiversion or defibrillation shock to treat a tachyarrhythmia of the patient'"'"'s heart.

19. The method of claim 10, wherein the implantable medical device is a cardiac pacemaker for delivering cardiac pacing pulses to the patient'"'"'s heart and wherein:

the storing step comprises storing an audio drive signal that is reproducible as the human understandable voiced statement indicative of the delivery of a pacing pulse;

the selecting step comprises selecting the audio drive signal indicative of the delivery of the pacing pulse upon delivery of the pacing pulse; and

the broadcasting step comprises broadcasting the modulated radio frequency signal in timed relation with the delivery of the pacing pulse that is detected and demodulated by the radio receiver to produce the human understandable voiced statement indicative of the delivery of the pacing pulse.

20. The method of claim 19, further comprising the step of:

sensing cardiac events and providing cardiac sense event signals; and

wherein;

the storing step comprises storing an audio drive signals indicative of the provision of a cardiac sense event signal;

the selecting step comprises selecting the audio drive signal in response to a cardiac sense event signal; and

the broadcasting step comprises broadcasting a modulated radio frequency signal in timed relation with the sense event signal that is detected and demodulated by the radio receiver to produce the human understandable voiced statement indicative of the cardiac sense event.

21. The method of claim 10, wherein the implantable medical device is an electrical stimulator for delivering electrical stimulation to body tissue, and wherein:

the storing step comprises storing an audio drive signal indicative of the delivery of electrical stimulation;

the selecting step comprises selecting the audio drive signal related to the delivery of electrical stimulation; and

the broadcasting step comprises broadcasting a modulated radio frequency signal that is detected and demodulated by the radio receiver to produce the human understandable voiced statement indicative of the delivery of electrical stimulation.

22. The method of claim 10, wherein the implantable medical device is a substance delivery system for delivering a substance to the patient'"'"'s body, and wherein:

the storing step comprises storing an audio drive signal indicative of the delivery of the substance to body tissue;

the selecting step comprises selecting the audio drive signal related to the delivery of the substance to body tissue; and

the broadcasting step comprises broadcasting a modulated radio frequency signal that is detected and demodulated by the radio receiver to produce the human understandable voiced statement indicative of the delivery of the substance to body tissue.

23. The method of claim 10, wherein the storing step further comprises the steps of:

providing a memory having memory locations denoted by memory addresses to store audio drive signals at specified memory addresses; and

storing audio drive signals comprising human understandable voiced statements signifying implantable medical device information at specified memory addresses of the memory; and

the step of selecting one or more stored audio drive signal for broadcast further comprises the steps of;

generating a memory address of a stored audio drive signal; and

retrieving the audio drive signal from the addressed memory location in response to a generated memory address.

24. The method of claim 23, wherein the plurality of audio drive signals correlated with specific parts of the medical device information are selected from the group that further comprises:

medical device manufacturer;

medical device identification;

patient identification;

date of implantation;

date of last interrogation;

stored physiologic data;

battery condition;

real time device operations;

current programmed operating modes;

current programmed operating parameter values;

depletion of a substance reservoir;

an impending device operation; and

a detected condition of the patient.

25. The method of claim 23, for broadcasting a message from an implantable medical device thorough a patient'"'"'s body to the radio receiver external to the patient'"'"'s body further comprising the step of:

monitoring a condition or state or impending operation or consummated operation of the implantable medical device or a condition or state of the patient and providing a message trigger signal in response thereto; and

wherein the generating step further comprises the step of;

generating the memory address of a stored audio drive signal of implantable medical device information in compliance with the message trigger signal.

26. The method of claim 25, wherein the messages stored as audio drive signals at specified memory addresses are selected from the group that further comprises:

physiologic patient condition;

battery condition;

depletion of a substance reservoir

an impending device operation; and

a consummated device operation which when reproduced by the radio receiver constitute human understandable voiced statements.

27. An implantable medical device having a communication system for communicating a message from the implantable medical device through a patient'"'"'s body to a radio receiver external to the patient'"'"'s body comprising:

monitoring means for monitoring a condition, state or impending operation of the implantable medical device or a condition or state of the patient and for providing a message trigger signal in response thereto; and

a memory to store at least one audio drive signal capable of being reproduced as a human understandable voiced statement conveying medical device information;

a radio frequency transmitter to broadcast radio frequency signals modulated by audio drive signals, the broadcast radio frequency signals capable of being received and demodulated by the radio receiver located outside the patient'"'"'s body; and

audio feedback means responsive to the message trigger signal for retrieving an audio drive signal from the memory and applying the retrieved audio drive signal to the radio frequency transmitter to cause the radio frequency transmitter to broadcast a modulated radio frequency signal that is detected and demodulated by the radio receiver to produce the human understandable voiced statement advising the patient of a condition, state or impending operation of the implantable medical device or a condition or state of the patient.

28. The device of claim 27, wherein:

the memory further comprises a plurality of memory locations denoted by memory addresses to store a plurality of audio drive signals which convey messages related to a condition, state or impending operation of the implantable medical device or a condition or state of the patient at specified memory addresses;

the monitoring means monitors a plurality of conditions, states or impending operations of the implantable medical device or conditions or states of the patient and provides message trigger signals related to each in response thereto; and

the audio feedback means further comprises;

means responsive to each specific message trigger signal for selectively generating a memory address of a stored audio drive signal; and

means responsive to a generated memory address for retrieving the audio drive signal from the addressed memory location and applying the retrieved audio drive signal to the radio frequency transmitter to cause the radio frequency transmitter to broadcast a modulated radio frequency signal that is detected and demodulated by the radio to produce a human understandable voiced statement conveying a message to the patient.

29. The device of claim 28, wherein the patient messages stored as audio drive signals at specified memory addresses are selected from the group that further comprises:

physiologic patient condition;

battery condition;

depletion of a substance reservoir;

an impending device operation; and

a consummated device operation which when reproduced by the radio receiver constitute human understandable voiced statements.

30. The device of claim 28, wherein the implantable medical device is powered by a battery and further comprises:

monitoring means for monitoring the power level of a battery that depletes with consumption of power by the implantable medical device and for providing a message trigger signal; and

wherein;

the memory stores an audio drive signal capable of being reproduced as a human understandable voiced statement conveying battery power level; and

the audio feedback means responds to the message trigger signal by retrieving the audio drive signal related to battery power level and applying the retrieved audio drive signal to the radio frequency transmitter to cause the radio frequency transmitter to broadcast a modulated radio frequency signal that is detected and demodulated by the radio receiver to produce a human understandable voiced statement warning indicative of the battery power level.

31. The device of claim 28, wherein the implantable medical device further comprises:

means for monitoring a physiologic condition of the patient;

means for determining the onset of a malignant condition of the patient from the monitored physiologic condition or state of the patient and providing a message trigger signal; and

wherein;

the memory stores an audio drive signal that is reproducible as a human understandable voiced statement conveying a warning to the patient of the determined onset of the malignant condition; and

the audio feedback means responds to the message trigger signal by retrieving the audio drive signal related to the determined malignant condition and applying the retrieved audio drive signal to the radio frequency transmitter to cause the radio frequency transmitter to broadcast a modulated radio frequency signal that is detected and demodulated by the radio receiver to produce a human understandable voiced statement warning of the malignant condition.

32. The device of claim 28, wherein the implantable medical device further comprises:

cardiac monitoring means for monitoring the patient'"'"'s heart;

means for determining the onset of a malignant tachyarrhythmia of the heart from the monitored heart and providing a message trigger signal; and

wherein;

the memory stores an audio drive signal that is reproducible as a human understandable voiced statement conveying a warning to the patient of the determined onset of the malignant tachyarrhythmia; and

the audio feedback means responds to the message trigger signal by retrieving an audio drive signal related to the determined malignant condition and applying the retrieved audio drive signal to the radio frequency transmitter to cause the radio frequency transmitter to broadcast a modulated radio frequency signal that is detected and demodulated by the radio receiver to produce a human understandable voiced statement warning indicative of the malignant tachyarrhythmia condition.

33. The device of claim 28, wherein the implantable medical device further comprises:

cardiac monitoring means for monitoring the patient'"'"'s heart;

cardiac therapy delivery means for delivering a cardioversion/defibrillation shock therapy to a patient'"'"'s heart in response to a detected tachyarrhythmia;

means for determining the onset of a malignant tachyarrhythmia of the heart from the monitored heart and providing a message trigger signal conveying a determined onset of a malignant tachyarrhythmia and impending delivery of a cardioversion/defibrillation shock therapy; and

wherein;

the memory stores an audio drive signal correlated to determination of onset of a malignant tachyarrhythmia and impending delivery of a cardioversion/defibrillation shock therapy; and

the audio feedback means responds to the message trigger signal by retrieving the audio drive signal related to the determined malignant tachyarrhythmia and applying the retrieved audio drive signal to the radio frequency transmitter to cause the radio frequency transmitter to broadcast a modulated radio frequency signal that is detected and demodulated by the radio receiver to produce a human understandable voiced statement warning indicative of the malignant tachyarrhythmia condition and impending delivery of a cardioversion/defibrillation shock therapy.

34. The system of claim 28, herein the implantable medical device is a substance delivery system for delivering a substance to the patient'"'"'s body, further comprising:

means for delivering substance dosages from the substance reservoir to the patient'"'"'s body; and

wherein;

the memory has a memory location denoted by a memory address to store an audio drive signal indicative of the delivery of a substance to body tissue; and

the audio feedback means responds to delivery of a substance by retrieving the audio drive signal related to the delivery of the substance and applying the retrieved audio drive signal to the radio frequency transmitter to cause the radio frequency transmitter to broadcast a modulated radio frequency signal capable of being detected and demodulated by the radio receiver to produce the human understandable voiced statement or the other audible sound indicative of the delivery of the substance.

35. The system of claim 28, wherein the implantable medical device is a substance delivery system for delivering a substance from a reservoir having a defined capacity to the patient'"'"'s body, that further comprises:

means for delivering substance dosages from the substance reservoir to the patient'"'"'s body; and

monitoring means for monitoring the quantity of substance delivered or remaining in the reservoir and for providing a message trigger signal when the substance reservoir is depleted; and

wherein;

wherein;

the memory has a memory location denoted by a memory address to store an audio drive signal signifying the depletion of the substance remaining in the reservoir; and

the audio feedback means responds to the message trigger signal by retrieving the audio drive signal related to the depletion of the substance remaining in the reservoir and applying the retrieved audio drive signal to the radio frequency transmitter to cause the radio frequency transmitter to broadcast a modulated radio frequency signal capable of being detected and demodulated by the radio receiver to produce the human understandable voiced statement or the other audible sound warning indicative of the depletion of the substance remaining in the reservoir.