Dosing limitation for an implantable medical device

• US 8,306,627 B2
• Filed: 05/23/2011
• Issued: 11/06/2012
• Est. Priority Date: 04/27/2007
• Status: Active Grant

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc
• Inventors: Armstrong, Randolph K.
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Stice, Paula J
• Application Number:
  US13/113,080
• Publication Number:
  US 20110224758A1
• Time in Patent Office: 533 Days
• Field of Search: 607/1, 607/7, 607 11- 15, 607 30- 32, 607/45
• US Class Current: 607/59
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/36164 Sub-threshold or non-excitatory signals non-excitatory signals to the heart A61N1/3628
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer

Abstract

An implantable medical device (IMD) including an input interface that operates to receive an external input and a stimulation mode controller coupled to the input interface. The stimulation mode controller operates to temporarily interrupt a normal stimulation mode of the IMD in response to the external input. The IMD also includes an alternative stimulation selection module coupled to the stimulation mode controller, the alternative stimulation selection module operating to determine whether to implement an alternative mode of electrical signal therapy based on the external input and a threshold. The alternative mode differs in at least one stimulation parameter from the normal stimulation mode. The stimulation mode controller further operates to implement the alternative mode of the electrical signal therapy based on the determination of the alternative stimulation selection module.

Claims

1. An implantable medical device (IMD) comprising:

an input interface configured to receive an external input;

a memory configured to store at least one threshold value;

a stimulation mode controller coupled to the input interface and the memory, the stimulation mode controller configured to temporarily interrupt a normal stimulation mode of the IMD in response to the external input;

an alternative stimulation selection module coupled to the stimulation mode controller, the alternative stimulation selection module configured to determine whether to implement an alternative mode of electrical signal therapy based on the external input, the at least one threshold value stored in the memory, and a time period, the alternative mode of electrical signal therapy differing in at least one stimulation parameter from the normal stimulation mode of the IMD; and

wherein the stimulation mode controller is further configured to implement the alternative mode of electrical signal therapy based on a determination of the alternative stimulation selection module.

2. The implantable medical device of claim 1, wherein the threshold value includes at least one of:

a maximum number of patient-initiated signals to provide a therapeutic electrical signal per the time period, a maximum dose of the therapeutic electrical signal per the time period, a maximum duration of the therapeutic electrical signal per the time period, a maximum rate of change of a number of therapeutic electrical signals per the time period, a maximum rate of change of the dose of the therapeutic electrical signal per the time period, or a maximum rate of change of the duration of the electrical signal therapy per the time period.

3. The implantable medical device of claim 1, wherein the alternative mode of electrical signal therapy includes at least one of:

a first electrical signal therapy to a cranial nerve, a second reduced electrical signal therapy to the cranial nerve, a third enhanced electrical signal therapy to the cranial nerve, or a background electrical signal to the cranial nerve.

4. The implantable medical device of claim 3, wherein the first electrical signal therapy comprises a first pulsed electrical signal defined by at least one stimulation parameter, including:

a first current amplitude, a first pulse width, a first frequency, a first on-time, a first off-time, a first number of pulses per burst, a first interburst period, or a first interpulse interval.

5. The implantable medical device of claim 4, wherein the second reduced electrical signal therapy comprises a second pulsed electrical signal defined by at least one stimulation parameter, including:

a second current amplitude less than the first current amplitude, a second pulse width less than the first pulse width, a second frequency less than the first frequency, a second on-time less than the first on-time, a second off-time greater than the first off-time, a second number of pulses per burst less than the first number of pulses per burst, a second interburst period greater than the first interburst period, or a second interpulse interval greater than the first interpulse interval.

6. The implantable medical device of claim 4, wherein the third enhanced electrical signal therapy comprises a third pulsed electrical signal defined by at least one stimulation parameters, including:

a third current amplitude greater than the first current amplitude, a third pulse width greater than the first pulse width, a third frequency greater than the first frequency, a third on-time greater than the first on-time, a third off-time less than the first off-time, a third number of pulses per burst greater than the first number of pulses per burst, a third interburst period less than the first interburst period, or a third interpulse interval less than the first interpulse interval.

7. The implantable medical device of claim 1, wherein the stimulation mode controller is further configured to inhibit at least one of:

an electrical signal therapy to a cranial nerve or a background electrical signal to the cranial nerve based on the determination of the alternative stimulation selection module.

8. The implantable device of claim 1, wherein the external input includes at least one of:

a patient initiated input or a detected body parameter input.

9. The implantable device of claim 8, wherein the detected body parameter input triggers electrical signal therapy.

10. The implantable device of claim 1, wherein the threshold value corresponds to at least one time period.

11. The implantable device of claim 10, wherein the at least one time period has a duration falling in a range of 10 seconds to 720 hours.

12. The implantable device of claim 10, wherein at least one time period represents a length of time ending at a present time and beginning at a time before the present time with an interval of the length of the time period.

13. The implantable device of claim 1, wherein the memory contains a plurality of threshold values specified for a plurality of time periods and corresponding to the plurality of time periods.

14. The implantable device of claim 13, wherein the plurality of time periods includes a first time period and a second time period, wherein the first and second time periods correspond to chronologically consecutive time frames or at least partially chronologically overlapping time frames.

15. The implantable device of claim 14, wherein the first and second time periods correspond to at least partially chronologically overlapping, time frames wherein the second time period is longer than the first time period, the first time period corresponding to a first threshold value stored in the memory and the second time period corresponding to a second threshold value stored in the memory.

16. The implantable device of claim 15, wherein the first threshold value is different from the second threshold value.

17. The implantable device of claim 1, wherein the input interface is configured to receive patient initiated input as a number of taps.

18. The implantable device of claim 1, wherein the input interface is configured to receive patient initiated input based on a magnetic field.

19. The implantable device of claim 18, wherein the patient initiated input corresponds to a magnetic field duration.

20. The implantable device of claim 18, wherein the patient initiated input corresponds to a magnetic field magnitude.