Dosing limitation for an implantable medical device

• US 7,974,701 B2
• Filed: 04/27/2007
• Issued: 07/05/2011
• 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:
  US11/741,096
• Publication Number:
  US 20080269839A1
• Time in Patent Office: 1,530 Days
• Field of Search: 607/2, 607 7- 15, 607 27- 32, 607 45- 46, 607 57- 64, 607115-120, 607145-150, 128/419
• 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 to a cranial nerve of a patient is provided. An electrical signal therapy limit is selected from the group consisting of; a maximum number of patient-initiated signals, a maximum dose of electrical signals, a maximum duration of electrical signal, a maximum rate of change of the number of patient-initiated signals, a maximum rate of change of the dose of electrical signals, and a maximum rate of change of the duration of the electrical signals all per unit of time. If the electrical signal therapy limit is exceeded a therapy is delivered to the cranial nerve selected from the group consisting of; providing therapy, providing reduced therapy, providing enhanced therapy, inhibiting therapy, providing background therapy, and inhibiting background therapy.

Claims

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

specifying an electrical signal parameter threshold;

wherein said electrical signal parameter is specific to the electrical signal therapy; and

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 therapeutic electrical signals per a time period, a maximum duration of the therapeutic electrical signals 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 an input from said patient to enter an alternative mode of electrical signal therapy;

wherein said alternative mode of electrical signal therapy comprises altering the electrical signal parameter of the electrical signal therapy and wherein said input from said patient to enter said alternative mode of electrical signal therapy also prompts a temporary interruption from a normal stimulation mode of electrical signal therapy provided by the IMD;

determining whether to implement said alternative mode of electrical signal therapy based on said electrical signal parameter threshold,

and performing said alternative mode of electrical signal therapy when said electrical signal parameter of said alternative mode of electrical signal therapy is below said threshold, and

not performing said alternative mode of electrical signal therapy when said electrical signal parameter of said alternative mode of electrical signal therapy is above said threshold, to inhibit the patient initiated electrical signal therapy provided by the IMD to the cranial nerve of the patient.

2. 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.

3. 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.

4. 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 patient-initiated therapeutic electrical signal, wherein the patient-initiated therapeutic signal prompts a temporary interruption from a normal stimulation mode of electrical signal therapy;

determining whether or not said patient-initiated electrical signal therapy limit will be exceeded if said receiving the patient-initiated signal to begin the patient-initiated electrical signal therapy is implemented;

performing an action when said limit is not exceeded, said action selected from the group consisting of providing an electrical signal therapy to said cranial nerve, providing a reduced electrical signal therapy to said cranial nerve, providing an enhanced electrical signal therapy to said cranial nerve and providing a background electrical signal to said cranial nerve; and

performing a different action when said limit is exceeded, said different action selected from the group consisting of inhibiting said patient-initiated electrical signal therapy to said cranial nerve.

5. The method of claim 4, 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.

6. The method of claim 4, 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.

7. The method of claim 4, wherein the at least one electrical signal therapy limit is specified for at least one time period.

8. The method of claim 7, wherein said at least one time period has a duration from about 10 sec to about 720 hr.

9. The method of claim 7, wherein the at least one electrical signal therapy limit is specified for a plurality of time periods.

10. The method of claim 4, 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.

11. 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 the cranial nerve of a the patient;

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;

receiving a patient-initiated signal to provide an electrical signal therapy to a the cranial nerve, wherein the patient-initiated signal prompts a temporary interruption from a normal stimulation mode of electrical signal therapy provided by the IMD;

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

providing the patient-initiated 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 the patient-initiated signal; and

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

12. The method of claim 11, wherein receiving said patient-initiated signal comprises receiving at least one of a tap input or a magnetic input.

13. The method of claim 11, wherein the at least one electrical signal therapy limit is specified for at least one time period.

14. The method of claim 11, wherein said step of providing the 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.

15. The method of claim 13, wherein said time period has a duration from about 10 sec to about 720 hr.