Audible sound confirmation of programming change in an implantable medical device

• US 6,044,301 A
• Filed: 03/31/1999
• Issued: 03/28/2000
• 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): Kamm, William E.
• Assistant Examiner(s): LAYNO, CARL HERNANDZ
• Application Number:
  US09/282,593
• Time in Patent Office: 363 Days
• Field of Search: 607/59, 607/2, 607/9, 607/31
• US Class Current: 607/31
• CPC Class Codes: A61N 1/37258 Alerting the patient
• CPC Class Codes: G16H 40/63 for local operation

Abstract

Methods and apparatus for confirming programming of implantable medical device (IMD) operating parameter values and operating modes 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. A method of audibly confirming a change in operation of an implantable medical device implanted in a patient in an audio frequency range to the patient or a medical care provider to confirm the change in operation comprising:

providing a programming signal to make a change in an operation of the implantable medical device;

effecting a change in the operation of the implantable medical device signified by the programming signal; and

emitting an audible sound comprising one of a user selectable human language and an ascending or descending musical tones from the implantable medical device that is transmitted through the patient'"'"'s body and signifies the change made in the operation of the implantable medical device.

2. The method of claim 1, wherein the emitting step further comprises:

generating an audio transducer drive signal; and

applying the audio transducer drive signal to an audio transducer located within the implantable device, thereby causing the audio transducer to emit the audible sound comprising said one of a user selectable human language and said ascending or descending musical tones when driven by the audio transducer drive signal.

3. The method of claim 2, wherein the audible sound comprising said ascending or descending musical tone signifies the change in the operation of the implantable medical device, and the emitting step further comprises:

storing at least one audio transducer drive signal for application to the audio transducer correlated to a change in an operation of the implantable medical device at a memory address of memory within the implantable medical device;

generating the memory address of the audio transducer drive signal correlated with the change in response to a change in the operation of the implantable medical device; and

retrieving and applying the audio transducer drive signal from the memory to the audio transducer in response to a memory address generated by the address generation means, whereby a musical tone accompanying the change in operation is emitted by the audio transducer means.

4. The method of claim 2, wherein the emitting step further comprises:

emitting a first musical tone comprising said ascending musical tones that signifies an increase in an operating parameter of the implantable medical device in response to a programming signal for increasing the therapy parameter; and

emitting a second musical tone comprising one of said descending musical tones that signifies a decrease in an operating parameter of the implantable medical device in response to a programming signal for decreasing the therapy parameter.

5. The method of claim 4, wherein the emitting step further comprises:

storing a first audio transducer drive signal for generating the ascending musical tone at a first memory address;

storing a second audio transducer drive signal for generating the second descending musical tone at a second memory address;

generating the first memory address of the first audio transducer drive signal in response to an increase in an operating parameter;

generating the second memory address of the second audio transducer drive signal in response to a decrease in an operating parameter;

in response to the first memory address, retrieving the first audio transducer drive signal from the memory and for applying the retrieved first audio transducer drive signal to the audio transducer to emit the ascending musical tone; and

in response to the second memory address, retrieving the second audio transducer drive signal from the memory and applying the retrieved second audio transducer drive signal to the audio transducer to emit the descending musical tone.

6. The method of claim 2, wherein the audible sound comprises a voiced statement of a user selectable human language that states the change in the operation of the implantable medical device, and the emitting step further comprises:

storing in memory at least one audio transducer drive signal at a memory address correlated to at least one change in an operation of the implantable medical device;

in response to a change in the operation of the implantable medical device, generating the memory address of the audio transducer drive signal correlated with the change; and

in response to a memory address generated by the address generation means, retrieving and applying the audio transducer drive signal from the memory to the audio transducer, whereby a voiced statement comprising a user selectable human language accompanying the change in operation is emitted by the audio transducer means.

7. The method of claim 2, wherein the audible sound comprises a plurality of voiced statements comprising user selectable human languages which each state a change in the operation of the implantable medical device, and the emitting step further comprises:

storing in memory a plurality of audio transducer drive signals each at a memory address correlated to a change in an operation of the implantable medical device;

in response to a change in the operation of the implantable medical device, generating the memory address of the audio transducer drive signal correlated with the change; and

in response to a generated memory address, retrieving and applying the audio transducer drive signal from the memory to the audio transducer, wherein at least one of said voiced statements comprising said user selectable human languages accompany the change in operation being emitted by the audio transducer means.

8. The method of claim 2, wherein the emitting step further comprises:

emitting a first voiced statement comprising a user selectable local human language that states an increase in an operating parameter of the implantable medical device; and

emitting a second voiced statement comprising a user selectable local human language that states a decrease in an operating parameter of the implantable medical device.

9. The method of claim 8, wherein the emitting step further comprises the steps of:

storing a first audio transducer drive signal for generating the first voiced statement in memory at a first memory address;

storing a second audio transducer drive signal for generating the second voiced statement in memory at a second memory address;

generating the first memory address of the first audio transducer drive signal in response to an increase in an operating parameter;

generating the second memory address of the second audio transducer drive signal in response to a decrease in an operating parameter;

in response to the first memory address, retrieving the first audio transducer drive signal from the memory and applying the retrieved first audio transducer drive signal to the audio transducer to emit the first voiced statement; and

in response to the second memory address, retrieving the second audio transducer drive signal from the memory and applying the retrieved second audio transducer drive signal to the audio transducer to emit the second voiced statement.

10. The method of claim 1, wherein the emitting step occurs when a patient or medical care provider performs the step of initiating delivery of a therapy or a change in a therapy, and wherein the implantable medical device is a therapy delivery device.

11. A system for audibly communicating a change in operation of an implantable medical device implanted in a patient in an audio frequency range to the patient or a medical care provider to confirm the change in operation comprising:

means for providing a programming signal to make a change in an operation of the implantable medical device;

means for effecting a change in the operation of the implantable medical device signified by the programming signal; and

sound emitting means for emitting an audible sound, comprising one of ascending or descending musical notes and a user selectable human language, from the implantable medical device that is transmitted through the patient'"'"'s body and signifies the change made in the operation of the implantable medical device.

12. The system of claim 11, wherein the sound emitting means further comprises:

means for generating an audio transducer drive signal; and

means for applying the audio transducer drive signal to an audio transducer located within the implantable device, thereby causing the audio transducer to emit said audible sound when driven by the audio transducer drive signal.

13. In conjunction with an implantable medical device, a system for emitting audible sounds, comprising one of ascending or descending musical notes and a user selectable human language, from the implantable medical device implanted in a patient that may be heard by the patient or a medical care provider to confirm a change in an operation of the implantable medical device comprising:

means selectively operable by a medical care provider or the patient for providing a programming signal to the implantable medical device to make a change in an operation of the implantable medical device;

operation control means located within the implantable medical device for controlling an operation thereof and responsive to the received programming signal for making a change in the operation of the implantable medical device signified by the programming signal;

audio transducer means located within the implantable device for emitting an audible sound when driven by an audio transducer drive signal; and

audio feedback means located within the implantable medical device and responsive to the operation control means for generating an audio transducer drive signal and applying the audio transducer drive signal to the audio transducer, to cause the audio transducer to emit said audible sounds comprising one of ascending or descending musical tones and a user selectable human language, signifying that a change has been made in the operation of the implantable medical device.

14. The system of claim 13, wherein the audio feedback means further comprises:

means for storing at least one audio transducer drive signal for application to the audio transducer correlated to a change in an operation of the implantable medical device at a memory address;

address generation means responsive to a change in the operation of the implantable medical device for generating the memory address of the audio transducer drive signal correlated with the change; and

retrieval means responsive to a memory address generated by the address generation means for retrieving and applying the audio transducer drive signal from the storage means to the audio transducer wherein said ascending or descending musical tones accompany the change in operation being emitted by the audio transducer means.

15. The system of claim 13, wherein the audible sounds include said ascending or descending musical tones wherein said ascending tone represents a first musical tone that signifies an increase in an operating parameter of the implantable medical device in response to a programming signal for increasing the operating parameter and said descending tone represents a second musical tone that signifies a decrease in the operating parameter of the implantable medical device in response to a programming signal for decreasing the operating parameter.

16. The system of claim 15, wherein the audio feedback means further comprises:

means for storing a first audio transducer drive signal for generating the first musical tone at a first memory address and a second audio transducer drive signal for generating the second musical tone at a second memory address;

address generation means responsive to an increase in an operating parameter for generating the first memory address of the first audio transducer drive signal and responsive to a decrease in an operating parameter for generating the second memory address of the second audio transducer drive signal; and

retrieval means responsive to the first memory address generated by the address generation means for retrieving the first audio transducer drive signal from the storage means and for applying the retrieved first audio transducer drive signal to the audio transducer to emit the first musical tone and responsive to the second memory address generated by the address generation means for retrieving the second audio transducer drive signal from the storage means and for applying the retrieved second audio transducer drive signal to the audio transducer to emit the second musical tone.

17. The system of claim 13, wherein the audible sounds comprising said ascending or descending musical tones include an increasing sequence of ascending scale musical tones that signify an incremental increase in an operating parameter of the implantable medical device in response to a programming signal for increasing the operating parameter and a decreasing sequence of descending scale musical tones that signify an incremental decrease in the operating parameter of the implantable medical device in response to a programming signal for decreasing the operating parameter.

18. The system of claim 17, wherein the audio feedback means further comprises:

means for storing a first audio transducer drive signal for generating the increase sequence of ascending scale musical tones at a first memory address and a second audio transducer drive signal for generating the decrease sequence of descending scale musical tones at a second memory address;

address generation means responsive to an increase in an operating parameter for generating the first memory address of the first audio transducer drive signal and responsive to a decrease in an operating parameter for generating the second memory address of the second audio transducer drive signal; and

retrieval means responsive to the first memory address generated by the address generation means for retrieving the first audio transducer drive signal from the storage means and for applying the retrieved first audio transducer drive signal to the audio transducer to emit the ascending scale musical tones accompanying an incremental increase in an operating parameter of the implantable medical device in response to a programming signal and responsive to the second memory address generated by the address generation means for retrieving the second audio transducer drive signal from the storage means and for applying the retrieved second audio transducer drive signal to the audio transducer to emit the descending scale musical tones accompanying an incremental decrease in an operating parameter of the implantable medical device in response to a programming signal.

19. The system of claim 13, wherein the audible sound comprises a user selectable voiced statement in a local human language that states the change in the operation of the implantable medical device, and the audio feedback means further comprises:

means for storing at least one audio transducer drive signal at a memory address correlated to at least one change in an operation of the implantable medical device;

address generation means responsive to a change in the operation of the implantable medical device for generating the memory address of the audio transducer drive signal correlated with the change; and

retrieval means responsive to a memory address generated by the address generation means for retrieving and applying the audio transducer drive signal from the storage means to the audio transducer, whereby said user selectable voiced statement accompanying the change in operation is emitted by the audio transducer means.

20. The system of claim 13, wherein the audible sound comprises a plurality of user selectable voiced statements in a human language that each state a change in the operation of the implantable medical device, and the audio feedback means further comprises:

means for storing a plurality of audio transducer drive signals each at a memory address correlated to a change in an operation of the implantable medical device;

address generation means responsive to a change in the operation of the implantable medical device for generating the memory address of the audio transducer drive signal correlated with the change; and

retrieval means responsive to a memory address generated by the address generation means for retrieving and applying the audio transducer drive signal from the storage means to the audio transducer, whereby a voiced statement accompanying the change in operation is emitted by the audio transducer means.

21. The system of claim 13, wherein the audible sound comprises said user selectable human language represents a first voiced statement in a local human language that states an increase in an operating parameter of the implantable medical device and a second voiced statement in a human language that states a decrease in an operating parameter of the implantable medical device, and the audio feedback means further comprises:

means for storing a first audio transducer drive signal at a first memory address correlated to an increase in an operating parameter of the implantable medical device and a second audio transducer drive signal at a second memory address correlated to a decrease in an operating parameter of the implantable medical device;

address generation means responsive to an increase in an operating parameter of the implantable medical device for generating the first memory address and responsive to a decrease in an operating parameter of the implantable medical device for generating the second memory address; and

retrieval means responsive to the first memory address generated by the address generation means for retrieving the first audio transducer drive signal from the storage means and for applying the retrieved first audio transducer drive signal to the audio transducer to emit the first voiced statement accompanying an incremental increase in an operating parameter of the implantable medical device in response to a programming signal and responsive to the second memory address generated by the address generation means for retrieving the second audio transducer drive signal from the storage means and for applying the retrieved second audio transducer drive signal to the audio transducer to emit the second voiced statement accompanying an incremental decrease in an operating parameter of the implantable medical device in response to a programming signal.

22. The system of claim 13, wherein the implantable medical device comprises a therapy delivery device and the change in operation or in an operating parameter is the delivery of a therapy or a change in a therapy delivered to the patient initiated by the patient and/or the medical care provider.