Dosing Limitation for an Implantable Medical Device

• US 20080269839A1
• Filed: 04/27/2007
• Published: 10/30/2008
• Est. Priority Date: 04/27/2007
• Status: Active Grant

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc
• Inventors: Armstrong, Randolph K.
• Granted Patent: US 7,974,701 B2
• Time in Patent Office: Days
• 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

A method for limiting patient-initiated electrical signal therapy provided by an implantable medical device (IMD) to a cranial nerve of a patient. At least one electrical signal therapy limit selected from the group consisting of a maximum number of patient-initiated signals to provide a therapeutic electrical signal per a time period, a maximum dose of the therapeutic electrical signal per a time period, a maximum duration of the therapeutic electrical signal per a time period, a maximum rate of change of the number of patient-initiated signals to provide a therapeutic electrical signal per a time period, a maximum rate of change of the dose of the therapeutic electrical signal per a time period, and a maximum rate of change of the duration of the electrical signal therapy per a time period is specified. A patient-initiated signal to begin a therapeutic electrical signal is received. Whether or not said electrical signal therapy limit is exceeded by said step of detecting a patient-initiated signal is determined. An action in response to said step of determining whether or not said limit is exceeded is performed, said action selected from the group consisting of providing a first electrical signal therapy to said cranial nerve, providing a second, reduced electrical signal therapy to said cranial nerve, providing a third, enhanced electrical signal therapy to said cranial nerve, inhibiting an electrical signal therapy to said cranial nerve, providing a background electrical signal to said cranial nerve, and inhibiting a background electrical signal to said cranial nerve.

Claims

1. A method for providing an alternative mode of electrical signal therapy provided by an implantable medical device (IMD) to a cranial nerve of a patient, comprising:

specifying a threshold of an electrical signal parameter;

receiving an input from a patient;

determining whether to implement the alternative mode based on said input and said threshold, said alternative mode differing in at least one neurostimulation parameter from a normal stimulation mode; and

performing the alternative mode of electrical signal therapy, in view of the result of the determining step, or

not performing the alternative mode of electrical signal therapy, in view of the result of the determining step.

2. The method of claim 1, wherein said threshold is selected from the group consisting of a maximum number of patient-initiated signals to provide a therapeutic electrical signal per a time period, a maximum dose of the therapeutic electrical signal per a time period, a maximum duration of the therapeutic electrical signal per a time period, a maximum rate of change of the number of patient-initiated signals to provide a therapeutic electrical signal per a time period, a maximum rate of change of the dose of the therapeutic electrical signal per a time period, and a maximum rate of change of the duration of the electrical signal therapy per a time period.

3. The method of claim 1, wherein said performing the alternative mode of electrical signal therapy is selected from the group consisting of providing a first electrical signal therapy to said cranial nerve, providing a second, reduced electrical signal therapy to said cranial nerve, providing a third, enhanced electrical signal therapy to said cranial nerve, and providing a background electrical signal to said cranial nerve.

4. The method of claim 1, wherein not performing said alternative mode comprises an action selected from the group consisting of inhibiting an electrical signal therapy to said cranial nerve and inhibiting a background electrical signal to said cranial nerve.

5. A method for limiting patient-initiated electrical signal therapy provided by an implantable medical device (IMD) to a cranial nerve of a patient, comprising:

specifying at least one electrical signal therapy limit selected from the group consisting of a maximum number of patient-initiated signals to provide a therapeutic electrical signal per a time period, a maximum dose of the therapeutic electrical signal per a time period, a maximum duration of the therapeutic electrical signal per a time period, a maximum rate of change of the number of patient-initiated signals to provide a therapeutic electrical signal per a time period, a maximum rate of change of the dose of the therapeutic electrical signal per a time period, and a maximum rate of change of the duration of the electrical signal therapy per a time period;

receiving a patient-initiated signal to begin a therapeutic electrical signal;

determining whether or not said electrical signal therapy limit is exceeded by said step of detecting a patient-initiated signal; and

performing an action in response to said step of determining whether or not said limit is exceeded, said action selected from the group consisting of providing a first electrical signal therapy to said cranial nerve, providing a second, reduced electrical signal therapy to said cranial nerve, providing a third, enhanced electrical signal therapy to said cranial nerve, inhibiting an electrical signal therapy to said cranial nerve, providing a background electrical signal to said cranial nerve, and inhibiting a background electrical signal to said cranial nerve.

6. The method of claim 5, further comprising determining a characteristic of said patient-initiated signal, wherein the patient-initiated signal is a magnetic field, comprising determining at least one of a duration of said magnetic field and a magnitude of said magnetic field, and wherein said characteristic is used in determining whether or not said electrical signal therapy limit is exceeded.

7. The method of claim 5, further comprising determining a characteristic of said patient-initiated signal, wherein the patient-initiated signal is a tap input, comprising determining a number of tap inputs received, and wherein said characteristic is used in determining whether or not said electrical signal therapy limit is exceeded.

8. The method of claim 5, wherein the at least one electrical signal therapy limit is specified for at least one time period.

9. The method of claim 8, wherein said at least one time period has a duration from about 10 sec to about 720 hr.

10. The method of claim 8, wherein the at least one electrical signal therapy limit is specified for a plurality of time periods.

11. The method of claim 5, wherein providing a first electrical signal therapy comprises providing a pulsed electrical signal defined by at least one parameter selected from the group consisting of 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, and a first interpulse interval;

wherein providing a second, reduced electrical signal therapy comprises providing a pulsed electrical signal defined by at least one parameter selected from the group consisting of a second current amplitude less than said first current amplitude, a second pulse width less than said first pulse width, a second frequency less than said first frequency, a second on-time less than said first on-time, a second off-time greater than said first off-time, a second number of pulses per burst less than said first number of pulses per burst, a second interburst period greater than said first interburst period, and a second interpulse interval greater than said first interpulse interval; and

wherein providing a third, enhanced electrical signal therapy comprises providing a pulsed electrical signal defined by at least one parameter selected from the group consisting of a third current amplitude greater than said first current amplitude, a third pulse width greater than said first pulse width, a third frequency greater than said first frequency, a third on-time greater than said first on-time, a third off-time less than said first off-time, a third number of pulses per burst greater than said first number of pulses per burst, a third interburst period less than said first interburst period, and a third interpulse interval less than said first interpulse interval.

12. A method for limiting patient-initiated electrical signal therapy provided by an implantable medical device (IMD) to a cranial nerve of a patient, comprising:

specifying at least one limit on patient-initiated electrical signal therapy to a cranial nerve of a patient;

receiving a patient-initiated signal to provide an electrical signal therapy to a cranial nerve;

determining whether or not said at least one limit on patient-initiated therapy is exceeded by said step of receiving a patient-initiated signal;

providing an electrical signal therapy to said cranial nerve of the patient if said at least one limit is not exceeded by said step of receiving a patient-initiated signal; and

not providing an electrical signal therapy to said cranial nerve of the patient if said at least one limit is exceeded by said step of receiving a patient-initiated signal.

13. The method of claim 12, wherein receiving said patient-initiated signal comprises receiving at least one of a tap input or a magnetic input.

14. The method of claim 12, wherein the at least one electrical signal therapy limit is specified for at least one time period.

15. The method of claim 12, wherein said step of providing an electrical signal therapy if said at least one limit is not exceeded comprises providing a pulsed electrical signal defined by at least one parameter selected from the group consisting of a current amplitude, a pulse width, a frequency, an on-time, an off-time, a number of pulses per burst, an interburst period, and an interpulse interval.

16. The method of claim 14, wherein said time period has a duration from about 10 sec to about 720 hr.

17. The method of claim 12, wherein the at least one limit is selected from the group consisting of a maximum number of patient-initiated signals to provide a therapeutic electrical signal per a time period, a maximum dose of the therapeutic electrical signal per a time period, a maximum duration of the therapeutic electrical signal per a time period, a maximum rate of change of the number of patient-initiated signals to provide a therapeutic electrical signal per a time period, a maximum rate of change of the dose of the therapeutic electrical signal per a time period, and a maximum rate of change of the duration of the electrical signal therapy per a time period.

18. A method for limiting patient-initiated electrical signal therapy provided by an implantable medical device (IMD) to a cranial nerve of a patient, comprising:

specifying at least one limit on patient-initiated electrical signal therapy to a cranial nerve of a patient;

receiving a patient-initiated signal to provide an electrical signal therapy to a cranial nerve;

determining whether or not said at least one limit on patient-initiated therapy is exceeded by said step of receiving a patient-initiated signal;

providing a first therapeutic electrical signal to said cranial nerve of the patient if said at least one limit is not exceeded by said step of receiving a patient-initiated signal; and

providing a second, reduced therapeutic electrical signal to said cranial nerve of the patient if said at least one limit is exceeded by said step of receiving a patient-initiated signal.

19. The method of claim 18, wherein said step of providing a first electrical signal therapy if said at least one limit is not exceeded comprises providing a pulsed electrical signal defined by at least one parameter selected from the group consisting of 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, and a first interpulse interval;

and

wherein said step of providing a second, reduced electrical signal therapy if said at least one limit is exceeded comprises providing a pulsed electrical signal defined by at least one parameter selected from the group consisting of a second current amplitude less than said first current amplitude, a second pulse width less than said first pulse width, a second frequency less than said first frequency, and second on-time less than said first on-time, a second off-time greater than said first off-time, a second number of pulses per burst less than said first number of pulses per burst, a second interburst period greater than said first interburst period, and a second interpulse interval greater than said first interpulse interval.

20. The method of claim 18, wherein receiving said patient-initiated signal comprises receiving at least one of a tap input or a magnetic input.