Audible sound communication from an implantable medical device

• US 6,082,367 A
• Filed: 04/29/1998
• Issued: 07/04/2000
• Est. Priority Date: 04/29/1998
• Status: Expired due to Term

• 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:
  US09/069,559
• Time in Patent Office: 797 Days
• Field of Search: 128/899, 128/904, 607/30-32, 607/59-60
• US Class Current: 128/899
• CPC Class Codes: A61N 1/37258 Alerting the patient
• CPC Class Codes: G16H 40/63 for local operation

Abstract

Methods and apparatus for communication of implantable medical device (IMD) information, including confirmation of programming and programmed parameter values, operating modes and programmed changes thereof and data stored in the IMD, by emission of audible sounds by the IMD are disclosed. The IMD includes an audio transducer that emits 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 audible sounds can comprise the sole uplink transmission or may augment the contemporaneous uplink RF transmission of stored data, and/or programmed operating modes and parameters and/or device operations and states in an interrogation or during programming. To conserve energy, the audible sounds accompanying interrogation and programming of the IMD are at a low volume that preferably cannot be heard without use of an external audio amplifier or stethoscope. Voiced statements warning of battery energy depletion or imminent delivery of a therapy are emitted at a higher volume that is sufficient to be heard by the patient, so that the patient can take appropriate action. The volume of audible sounds confirming programmed changes made by a patient using a limited function programmer or magnet is also increased so that the patient can hear them.

Claims

1. In conjunction with an implantable medical device (IMD), a system for communicating audible sounds denoting implantable medical device information of an implantable medical device during a communication session with the implantable medical device and an audible warning from the implantable medical device implanted in a patient to advise the patient to take appropriate action, the system comprising:

means for providing a communication link signal from a location outside the body of the patient to initiate a communication session with the implantable medical device;

receiving means located within the implantable medical device for receiving the communication link signal and commencing the communication session;

monitoring means for monitoring an operation of said implantable medical device indicative of a danger to the patient and for providing a warning trigger signal in response thereto;

audible sound emitting means responsive to the commencement of the communication session for emitting at least a first audible sound in an audio frequency range audibly hearable by the patient and/or medical care provider from the implantable medical device that is transmitted through the patient'"'"'s body and conveys implantable medical device information and responsive to the warning provided by said monitoring means for emitting a second audible sound in an audio frequency range audibly hearable by the patient or medical care provider from the implantable medical device that is transmitted through the patient'"'"'s body and conveys the warning to advise the patient to take appropriate action wherein the audible sound emitting means includes energy conservation means to generate low volume which is not human audible without the use of an external audio amplifier or stethoscope.

2. The system of claim 1, wherein said audible sound emitting means emits said first audible sound at a volume that is too low to be audible to the patient or medical care provider unless it is amplified and emits said second audible sound at a volume that is sufficient to be audible to the patient and/or medical care provider;

and further comprising;

means operable from a location exterior to the patient'"'"'s body for amplifying the first audible sound transmitted through the patient'"'"'s body so that the first audible sound is audibly hearable by the patient and/or the medical care provider wherein the first audible sound relates to communication other than interrogation and programming of the IMD.

3. The system of claim 1, wherein said audible sound emitting means further comprises:

an audio transducer located within said implantable medical device;

memory means having memory locations denoted by memory addresses for storing a first audio transducer drive signal at a first memory address for application to said audio transducer correlated to the implantable medical device information and a second audio transducer drive signal at a second memory address for application to said audio transducer correlated to the warning;

means for generating the first memory address of the first audio transducer drive signal when a communication session is commenced;

means for generating the second memory address of the second audio transducer drive signal when said warning trigger signal is generated;

retrieval means for using the generated first memory address to retrieve the first audio transducer drive signal from said memory and apply the first audio transducer drive signal to said audio transducer and for using the generated second memory address to retrieve the second audio transducer drive signal from said memory and apply the second audio transducer drive signal to said audio transducer; and

amplification means for amplifying said second audio transducer drive signal to a signal level for driving said audio transducer to emit said second audible sound at a volume that is sufficient to be audible to the patient and/or medical care provider.

4. The system of claim 3, wherein:

said memory means further comprises means for storing a plurality of said first audio transducer drive signals correlated with specific parts of said medical device information 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;

real time device operations;

current programmed operating modes; and

current programmed operating parameter values at a like plurality of first memory addresses; and

said audible sound emitting means further comprises means for sequentially addressing each of the selected plurality of first memory addresses to retrieve the plurality of first audio transducer drive signals from said memory means and apply said selected plurality of first audio transducer drive signals sequentially to said audio transducer wherein said last interrogation, said programmed operating modes and said programmed operating parameter values relate to interrogation and programming of the IMD and are at a low volume to be heard only by an external amplifier or stethoscope.

5. The system of claim 4, wherein:

said implantable medical device further comprises a power source that depletes with consumption of power by said implantable medical device; and

said monitoring means monitors depletion of said power supply and provides a warning trigger signal in response to a predetermined depletion of the power source, whereby the patient is warned of power supply depletion by emission of said second audible signal.

6. The system of claim 1, wherein said monitoring means monitors the onset of a malignant condition of the patient and provides said warning trigger signal in response to the detection thereof, whereby the patient is warned to seek medical assistance or take other precautions by emission of said second audible signal wherein said audible signal being different from warning signals relating to interrogation and programming of the IMD.

7. The system of claim 1, wherein:

said monitoring means monitors the onset of the malignant condition of the patient and provides said warning trigger signal in response to the detection is thereof, whereby the patient is warned to seek medical assistance or take other precautions by emission of said second audible signal; and

said implantable medical device further comprises means for treating a malignant condition of the patient detected by said monitoring means.

8. The system of claim 7, wherein said implantable medical device is an automatic cardioverter/defibrillator for monitoring an arrhythmia of a heart chamber and applying cardioversion/defibrillation shocks to the heart chamber.

9. The system of claim 1, wherein said audible sound emitting means further comprises:

means for emitting a plurality of said first audible sounds correlated with specific parts of said medical device information 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;

real time device operations;

current programmed operating modes; and

current programmed operating parameter values wherein said last interrogation, said programmed operating modes and said programmed operating parameter values relate to interrogation and programming of the IMD and are at a low volume to be heard only by an external amplifier or stethoscope.

10. The system of claim 1, wherein each of said first and second audible sounds comprise voiced statements in a local human language that convey the medical device information and the warning.

11. The system of claim 10, wherein the local human language is selectable by a user.

12. The system of claim 1, wherein said second audible sound comprises a voiced statement in a local human language that conveys the warning.

13. The system of claim 12, wherein the local human language is selectable by a user.

14. The system of claim 1, wherein said second audible sound comprises a musical tone that conveys the warning wherein said audible sound is different from warning signals relating to interrogation and programming of the IMD.

15. The system of claim 1, wherein each of said first audible sounds comprise voiced statements in a local human language that convey the medical device information and said second audible sound comprises a musical tone that conveys the warning.

16. The system of claim 15, wherein the local human language is selectable by a user.

17. A method for communicating implantable medical device information of an implantable medical device and a warning from the implantable medical device implanted in a patient to advise the patient to take appropriate action, the method comprising the steps of:

periodically initiating a communication session with the implantable medical device by;

providing a communication link signal from a location outside the body of the patient;

receiving the communication link signal by receiver means located within the implantable medical device;

commencing the communication session in response to the communication link signal; and

emitting at least a first audible sound from the implantable medical device that is transmitted through the patient'"'"'s body and conveys implantable medical device information during the communication session; and

monitoring said implantable medical device for determination of an operation or state of indicative of a danger to the patient comprising the steps of;

providing a warning trigger signal in response to determining an operation or state of said implantable medical device indicative of a danger to the patient; and

emitting a second audible sound from the implantable medical device that is transmitted through the patient'"'"'s body and conveys the warning to advise the patient to take appropriate action in response to the warning trigger signal.

18. The method of claim 17 wherein:

said step of emitting said first audible sound further comprises emitting said first audible sound at a volume that is too low to be audible to the patient or medical care provider unless it is amplified; and

said step of emitting said second audible sound further comprises emitting said second audible sound at a volume that is sufficient to be audible to the patient and/or medical care provider; and

further comprising the step of;

amplifying the first audible sound transmitted through the patient'"'"'s body from a location exterior to the patient'"'"'s body during the interrogation routine so that the first audible sound is hearable by the patient and/or the medical care provider.

19. The method of claim 17 further comprising the steps of:

providing an audio transducer located within said implantable medical device; and

providing memory means having memory locations denoted by memory addresses within said implantable medical device;

storing a first audio transducer drive signal at a first memory address correlated to the implantable medical device information for application to said audio transducer; and

storing a second audio transducer drive signal at a second memory address correlated to the warning for application to said audio transducer; and

wherein;

said step of emitting a first audible sound further comprises the steps of;

generating the first memory address of the first audio transducer drive signal when a communication session is commenced;

using the generated first memory address to retrieve the first audio transducer drive signal from said memory; and

applying the first audio transducer drive signal to said audio transducer to emit said first audible sound; and

said step of emitting a second audible sound further comprises the steps of;

generating the second memory address of the second audio transducer drive signal when said warning trigger signal is generated;

using the generated second memory address to retrieve the second audio transducer drive signal from said memory; and

applying the second audio transducer drive signal to said audio transducer to emit said second audible sound.

20. The method of claim 19 wherein said step of emitting said second audible sound further comprises the step of amplifying said second audio transducer drive signal to a signal level for driving said audio transducer to emit said second audible sound at a volume that is sufficient to be audible to the patient and/or medical care provider.

21. The method of claim 19 wherein:

said step of emitting said first audible sound further comprises emitting said first audible sound at a volume that is too low to be audible to the patient and/or medical care provider unless it is amplified; and

further comprising the step of;

amplifying the first audible sound transmitted through the patient'"'"'s body from a location exterior to the patient'"'"'s body during the interrogation routine so that the first audible sound is hearable by the patient and/or the medical care provider.

22. The method of claim 17 wherein

said step of emitting said first audible sound further comprises emitting said first audible sound at a volume that is too low to be audible to the patient or medical care provider unless it is amplified;

and

said step of emitting said second audible sound further comprises emitting said second audible sound at a volume that is sufficient to be audible to the patient or medical care provider; and

further comprising the step of;

amplifying the first audible sound transmitted through the patient'"'"'s body from a location exterior to the patient'"'"'s body during the interrogation routine so that the first audible sound is hearable by the patient and/or the medical care provider.

23. The method of claim 17, wherein said step of storing a first audio transducer drive signal at a first memory address correlated to the read implantable medical device information for application to said audio transducer further comprises the step of:

storing a plurality of said first audio transducer drive signals correlated with specific parts of said medical device information 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;

real time device operations;

current programmed operating modes; and

current programmed operating parameter values at a like plurality of first memory addresses; and

said step of emitting a first audible sound further comprises the steps of;

sequentially generating the memory addresses of each of the

selected plurality of first memory addresses;

retrieving the selected plurality of first audio transducer drive signals from said memory means; and

applying said selected plurality of first audio transducer drive signals sequentially to said audio transducer to emit a sequence of said first audible sounds.

24. The method of claim 17, wherein each of said first and second audible sounds comprise voiced statements in a local human language that convey the medical device information and the warning.

25. The method of claim 17, wherein the local human language is selectable by a user.

26. The method of claim 17, wherein said implantable medical device further comprises a power source that depletes with consumption of power by said implantable medical device, and said monitoring step further comprises the steps of:

monitoring depletion of said power supply; and

providing a warning in response to a predetermined depletion of the power source, whereby the patient is warned of power supply depletion by emission of said second audible signal indicative thereof.

27. The method of claim 17, wherein said monitoring step further comprises the steps of:

monitoring the onset of a malignant condition of the patient; and

providing said warning in response to the detection thereof, whereby the patient is warned to seek medical assistance or take other precautions by emission of said second audible signal indicative thereof.

28. The method of claim 17, wherein said second audible sound comprises a voiced statement in a human language that conveys the warning.

29. The method of claim 17, wherein said second audible sound comprises a musical tone that conveys the warning.

30. The method of claim 17, wherein each of said first audible sounds comprise voiced statements in a local human language that convey the medical device information and said second audible sound comprises a musical tone that conveys the warning.

31. The method of claim 30, wherein the local human language is selectable by a user.