Interrogation of an implantable medical device using broadcast audible sound communication

• US 6,370,433 B1
• Filed: 01/25/2000
• Issued: 04/09/2002
• 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): Getzow, Scott M.
• Application Number:
  US09/491,205
• Time in Patent Office: 805 Days
• Field of Search: 607/30, 607/31, 607/32
• US Class Current: 607/32
• 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 1/3727 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 is 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 system for interrogating stored and real time generated implantable medical device information of an implantable medical device implanted in a patient and broadcasting the interrogated implantable medical device information to a radio receiver external to the patient'"'"'s body, the system comprising:

means for providing an interrogation signal from a location outside the patient'"'"'s body to initiate an interrogation routine of the implantable medical device information; and

the implantable medical device further comprises;

receiving means for receiving the interrogation signal and commencing the interrogation routine;

means for storing at least one audio drive signal capable of being reproduced as a human understandable voiced statement or other audible sound signifying medical device information;

a radio frequency transmitter for broadcasting 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 commencement of the interrogation routine for retrieving a stored audio drive signal 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 signifying the implantable device information being interrogated.

2. The system of claim 1, wherein the medical device information is 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,

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

3. The system of claim 1, wherein:

the means for storing at least one audio drive signal comprises a memory having a plurality of memory locations denoted by memory addresses to store a plurality of audio drive signals at specified memory addresses; and

the audio feedback means further comprises;

means 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.

4. The system of claim 3, wherein the medical device information stored as audio drive signals at specified memory addresses 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;

device operation history; and

a detected condition of the patient,

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

5. The system of claim 1, wherein the interrogation routine comprises performance of a real time device operation and the at least one audio drive signal signifies the real time device operation of the implantable medical device, the implantable medical device further comprising:

means for performing the real time device operation in response to the interrogation signal;

and wherein the audio feedback means further comprises;

means for retrieving an audio drive signal correlated with the performance of the real time device operation of the implantable medical device; and

means for applying the retrieved audio drive signal to the radio frequency transmitter to cause the radio frequency transmitter to broadcast a modulated radio frequency signal in timed relation with performance of the real time device operation, whereby the human understandable voiced statement or audible sound is generated by the radio receiver in timed relation to the operation of the implantable medical device.

6. The system of claim 5, wherein the real time device operation and the correlated audio drive signal or signals are selected from the group that further comprises:

monitoring a physiologic patient condition;

determining battery condition; and

delivering a therapy to the patient.

7. The system of claim 5, 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 means stores at least one audio drive signal capable of being reproduced as the human understandable voiced statement or sound conveying battery power level;

the providing means further comprises providing a power level interrogation command;

the real time device operation performing means causes the battery power level to be measured as the real time device operation; and

the retrieving means retrieves a stored audio drive signal signifying the measured battery 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 message indicative of the battery power level.

8. The system of claim 5, wherein the implantable medical device is a substance delivery system for delivering a substance in substance dosages from a reservoir having a defined capacity to the patients body, and wherein:

the storing means stores an audio drive signal signifying the quantity of substance delivered or remaining in the reservoir;

the providing means provides a substance quantity interrogation command that causes the quantity of substance delivered or remaining in the reservoir to be measured;

the real time device operation performing means causes the quantity of substance delivered or remaining in the reservoir to be measured as the real time device operation; and

the retrieving means retrieves a stored audio drive signal signifying the quantity of substance delivered or remaining in the reservoir to be measured,

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 message indicative of the quantity of substance delivered or remaining in the reservoir.

9. The system of claim 5, wherein the implantable medical device is an electrical stimulator for delivering electrical stimulation to the patients body tissue that further comprises:

means for delivering electrical stimulation to the patient'"'"'s body tissue; and

wherein;

the storing means stores at least one audio drive signal that signifies the delivery of the electrical stimulation; and

the providing means provides an interrogation command that causes the retrieving means to retrieve the stored audio drive signal signifying the delivery of the electrical stimulation each time that the electrical stimulation is delivered,

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 message indicative of the delivery of the electrical stimulation.

10. The system of claim 9, wherein the implantable medical device is a cardiac pacemaker, and the electrical stimulation comprises cardiac pacing pulses delivered to the patient'"'"'s heart.

11. The system of claim 5, wherein the implantable medical device is a cardiac monitor for monitoring electrical activity of the patient'"'"'s heart that further comprises:

means for detecting electrical activity of the patient'"'"'s heart and providing a cardiac signal in response to detected electrical activity; and

wherein;

the storing means stores at least one audio drive signal that signifies the cardiac signal; and

the providing means provides an interrogation command that causes the retrieving means to retrieve the stored audio drive signal signifying the detected electrical activity of the heart each time that the cardiac signal is provided,

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 message indicative of the cardiac signal.

12. A method for interrogating implantable medical device information and communicating interrogated 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 comprising human understandable voiced statements or audible sounds signifying implantable medical device information within the implantable medical device;

providing an interrogation signal from a location outside the patient'"'"'s body to initiate an interrogation routine of the implantable medical device;

selecting one or more stored audio drive signal of implantable medical device information in compliance with the interrogation routine;

broadcasting radio frequency signals modulated by selected audio drive signals, the broadcast radio frequency signals capable of being received and demodulated by the radio receiver to produce human understandable voiced statements or the other audible sounds; and

receiving, demodulating and reproducing the human understandable voiced statements or the other audible sounds through the radio receiver.

13. The method of claim 12, 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;

device history operation; and

a detected condition of the patient.

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;

the providing step further comprises providing a power level interrogation command that causes the battery power level to be measured; and

the selecting step further comprises selecting the stored audio drive signal signifying the measured battery 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 message indicative of the battery power level.

15. The method of claim 12, wherein the implantable medical device is a substance delivery system for delivering a substance in substance dosages from a reservoir having a defined capacity to the patient'"'"'s body, and wherein:

the storing step comprises storing an audio drive signal signifying the quantity of substance delivered or remaining in the reservoir;

the providing step further comprises providing a substance quantity interrogation command that causes the quantity of substance delivered or remaining in the reservoir to be measured; and

the selecting step comprises selecting the audio drive signal signifying the quantity of substance delivered or remaining in the reservoir,

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 message indicative of the quantity of substance delivered or remaining in the reservoir.

16. The method of claim 12, 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 or audible sounds 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 one or more stored audio drive signal of implantable medical device information in compliance with the interrogation routine; and

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

17. The method of claim 16, wherein the medical device information stored as audio drive signals at specified memory addresses 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;

device operation history; and

a detected condition of the patient.

18. The method of claim 12, wherein the interrogation routine comprises performance of a real time device operation and the at least one audio drive signal signifies the real time device operation of the implantable medical device, wherein:

the storing step further comprises storing an audio drive signal capable of being reproduced as the human understandable voiced statement or sound conveying performance of the real time device operation;

the providing step further comprises providing an interrogation command that causes the real time device operation to be performed; and

the selecting step comprises selecting the audio drive signal signifying the performance of the real time device operation,

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 message indicative of the performance of the real time device operation.

19. The method of claim 18, wherein the real time device operation and the correlated audio drive signal or signals are selected from the group that further comprises:

monitoring a physiologic patient condition;

determining battery condition; and

delivering a therapy to the patient.

20. The method of claim 12, wherein the implantable medical device is an electrical stimulator for delivering electrical stimulation to the patient'"'"'s body tissue, and wherein:

the storing step comprises storing an audio drive signal that signifies the delivery of the electrical stimulation to the patient'"'"'s body tissue; and

the providing step further comprises providing an interrogation command that causes the selecting step to select the stored audio drive signal signifying the delivery of the electrical stimulation each time that the electrical stimulation is delivered,

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 message indicative of the delivery of the electrical stimulation.

21. The method of claim 20, wherein the implantable medical device is a cardiac pacemaker, and the electrical stimulation comprises cardiac pacing pulses delivered to the patients heart.

22. The method of claim 12, wherein the implantable medical device is a cardiac monitor for monitoring electrical activity of the patients heart and providing a cardiac signal in response to detected electrical activity;

and wherein;

the storing step comprises storing an audio drive signal that signifies the cardiac signal; and

the providing step further comprises providing an interrogation command that causes the selecting step to select the stored audio drive signal signifying the detected electrical activity of the heart each time that the cardiac signal is provided,

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 message indicative of the cardiac signal.

23. A system for interrogating stored and real time generated implantable medical device information of an implantable medical device implanted in a patient and broadcasting the interrogated implantable medical device information through the patients body to a radio receiver external to the patient'"'"'s body, the system comprising:

means located outside the patient'"'"'s body and selectively operable by a medical care provider and/or the patient for providing an interrogation signal to the implantable medical device to commence an interrogation routine of the implantable medical device; and

wherein the implantable medical device further comprises;

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

receiving means for receiving the interrogation signal and commencing an interrogation routine;

reading means responsive to the received interrogation signal for reading implantable medical device information in accordance with the interrogation routine;

a radio frequency transmitter for broadcasting 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 for retrieving the audio drive signal from the memory correlated with the read implantable medical device information 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 conveys the read implantable medical device information, whereby the broadcast radio frequency signal is capable of being detected and demodulated by the radio receiver to produce the human understandable voiced statement or the other audible sound.

24. The system of claim 23, wherein:

the memory stores a plurality of audio drive signals correlated with specific parts of the medical device information; and

wherein;

the reading means further comprises means for retrieving the plurality of audio drive signals in a predetermined sequence; and

the audio feedback means retrieves the audio drive signals from the memory and applies the retrieved audio drive signals to the radio frequency transmitter in the predetermined sequence to cause the radio frequency transmitter to broadcast a sequence of modulated radio frequency signals that conveys the read implantable medical device information, whereby the broadcast radio frequency signals are capable of being detected and demodulated by the radio to produce human understandable voiced statements or the other audible sounds.

25. The system of claim 24, 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;

device operation history; and

a detected condition of the patient.

26. The system of claim 23, wherein the interrogation routine comprises performance of a real time device operation and the audio drive signal stored in memory signifies the real time device operation of the implantable medical device, the implantable medical device further comprising:

means for performing the real time device operation in response to the interrogation signal; and

wherein the audio feedback means further comprises;

means for generating the memory address of the audio drive signal correlated with the performance of the real time device operation of the implantable medical device; and

means responsive to the generated memory address for retrieving the 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 in timed relation with performance of the real time device operation, whereby the human understandable voiced statement or audible sound is generated by the radio receiver in timed relation to the operation of the implantable medical device.

27. The system of claim 26, wherein the real time device operation and the correlated audio drive signal or signals stored in memory are selected from the group that further comprises:

monitoring a physiologic patient condition;

determining battery condition; and

delivering a therapy to the patient.

28. The system of claim 26, wherein the implantable medical device is a cardiac pacemaker that further comprises:

means for delivering pacing pulses to the patient'"'"'s heart as the real time operation; and

wherein;

the memory has a memory location denoted by a memory address to store an audio drive signal that signifies the delivery of the pacing pulse; and

the audio feedback means further comprises;

means responsive to delivery of a pacing pulse for selectively generating the memory address of the stored audio drive signal that signifies the delivery of the pacing pulse; 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 capable of being detected and demodulated by the radio to produce the human understandable voiced statement or the other audible sound conveying delivery of the pacing pulse.

29. The system of claim 26, wherein the implantable medical device is a cardiac pacemaker that further comprises:

means for delivering pacing pulses to the patient'"'"'s heart as the real time operation; and

means for sensing cardiac events as the real time operation and providing a sense event signal; and

wherein;

the memory has memory locations denoted by memory addresses to store a first audio drive signal at a first memory address that signifies the delivery of the pacing pulse and a second audio drive signal at a second memory address that signifies a sensed cardiac event and

the audio feedback means further comprises;

means responsive to delivery of a pacing pulse for selectively generating the first memory address of the stored first audio drive signal that signifies the delivery of the pacing pulse;

means responsive to a sense event signal for selectively generating the second memory address of the stored first audio drive signal that signifies the sensed cardiac event; and

means responsive to a generated first 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 capable of being detected and demodulated by the radio to produce the human understandable voiced statement or the other audible sound conveying delivery of the pacing pulse and responsive to a generated second 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 capable of being detected and demodulated by the radio to produce the human understandable voiced statement or the other audible sound conveying a sensed cardiac event in timed relation therewith.

30. The system of claim 26 wherein the implantable medical device is an electrical stimulator for delivering electrical stimulation to body tissue that further comprises:

means for delivering electrical stimulation to the patient'"'"'s body tissue as the real time operation; and

wherein;

the memory has a memory location denoted by a memory address to store an audio drive signal that signifies the delivery of the electrical stimulation; and

the audio feedback means further comprises;

means responsive to delivery of electrical stimulation for selectively generating the memory address of the stored audio drive signal that signifies the delivery of the electrical stimulation; 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 capable of being detected and demodulated by the radio to produce the human understandable voiced statement or the other audible sound conveying delivery of the electrical stimulation.

31. The system of claim 23, 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

wherein;

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

the interrogation signal providing means provides a substance quantity interrogation command that causes the quantity of substance delivered or remaining in the reservoir to be measured; and

the audio feedback retrieving means retrieves the stored audio drive signal signifying the quantity of substance delivered or remaining in the reservoir to be measured and applies it to the radio frequency transmitter,

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 message indicative of the quantity of substance delivered or remaining in the reservoir.