Key fob controller for an implantable neurostimulator

• US 8,954,148 B2
• Filed: 06/28/2011
• Issued: 02/10/2015
• Est. Priority Date: 06/28/2011
• Status: Active Grant

• Current Assignee: Cirtec Medical Corp., Qig Group LLC
• Original Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Inventors: Labbe, Michael, Wilder, Steven, Cottrill, Ben, Gagnon, Jeff
• Primary Examiner(s): Musselman, Timothy A
• Application Number:
  US13/170,558
• Publication Number:
  US 20130004925A1
• Time in Patent Office: 1,323 Days
• Field of Search: 607/1, 607 27- 46, 434/262
• US Class Current: 607/30
• CPC Class Codes: A61N 1/36128 Control systems
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators

Abstract

Devices, systems, and methods incorporate the most-used functions of a electrical stimulator'"'"'s controller into a small, thin pocket controller that is not only comfortable to carry in a pocket, but can also be attached to a key ring, lanyard, or other such carrying device for ease of daily use. A separate patient controller charger is used to charge and control the implanted medical device.

Claims

1. A pocket controller that is operable by a patient and that is configured to adjust a plurality of operational parameters defining a stimulation program to be performed by an implantable medical device within the patient, the pocket controller comprising:

a housing comprising a smaller form factor than a form factor of a patient controller that offers a greater number of control options than the pocket controller and that also communicates with the implantable medical device to adjust a plurality of the operational parameters of the implantable medical device, wherein the plurality of operational parameters adjustable with the pocket controller is less than a plurality of operational parameters that are adjustable by the patient controller;

a user interface configured to receive input from the patient to select, from the plurality of operational parameters adjustable with the pocket controller, configured to receive a selected operational parameter that is to be adjusted by the patient using the pocket controller, and configured to receive input from the patient indicating an adjustment to the selected operational parameter;

a communication module that is configured to be compatible with a receiver provided to the implantable medical device to transmit a signal indicative of the adjustment from the pocket controller to the implantable medical device and that is configured to receive information from the implantable medical device; and

a control module comprising a processor that is configured to convey the signal indicative of the adjustment entered via the user interface to the communication module to be transmitted to the implantable medical device, wherein

said control module is configured to communicate with the implantable medical device using said communication module to request information from said implantable medical device about which stimulation programs are currently available in the implantable medical device for use by the user, said information being stored in the control module, wherein

said control module is adapted for accepting user inputs for modifying settings of those stimulation programs currently available in the implantable medical device.

2. The pocket controller of claim 1, wherein the plurality of operational parameters that are adjustable by the patient controller comprise at least an amplitude of an individual electrical pulse relative to an amplitude of another electrical pulse in a series of electrical pulses emitted by the implantable medical device.

3. The pocket controller of claim 2, wherein the user interface is operable to collectively adjust, as a group, a global amplitude of the electrical pulses in the series of electrical pulses emitted by the implantable medical device.

4. The pocket controller of claim 1, wherein the user interface comprises:

a first input device that is operable by the patient to identify the selected operational parameter from the plurality of operational parameters to be adjusted by the pocket controller, and

a second input device that is operable by the patient to initiate the adjustment of the selected operational parameter.

5. The pocket controller of claim 1 further comprising a display device that displays at least one of:

a status of a battery provided to the implantable medical device;

a status of a battery provided to power the pocket controller;

an operational status of the implantable medical device; and

information related to a setting of the selected operational parameter.

6. The pocket controller of claim 5, wherein the information related to the setting of the selected operational parameter is to be displayed by the display device, and the information related to the setting of the selected operational parameter comprises at least one of:

an amplitude of electrical pulses emitted by the implantable medical device, and a predetermined program defining one or more of the plurality of operational parameters to be executed by the implantable medical device.

7. The pocket controller of claim 1 further comprising a connector that is cooperable with at least one of:

a key ring couples at least one key to the pocket controller, and a tether to be worn by the patient to couple the pocket controller to the patient.

8. A system for treating a patient, the system comprising:

an implantable medical device that is configured to be implanted in the patient to execute stimulation programs to be performed on the patient, wherein said internal treatment routine is governed by a plurality of operational parameters;

a clinician programmer configured for use by a health care provider for programming the implantable medical device with the stimulation programs;

a patient controller that is configured to communicate with the implantable medical device and is also configured to be placed in possession of the patient to allow the patient to adjust a plurality of the operational parameters of the stimulation programs previously programmed by the clinician programmer in the implantable medical device that is implanted in the patient; and

a pocket controller that is configured to communicate with the implantable medical device for requesting information from said implantable medical device about which stimulation programs are currently available in the implantable medical device for use by the user, said pocket controller being configured to be placed in possession of the patient, said pocket controller comprising a smaller form factor than a form factor of the patient controller, wherein said pocket controller is configured to be usable by the patient to adjust a plurality of, but less than all of the operational parameters of the stimulation programs currently available in implantable medical device that are adjustable with the patient controller, said pocket controller comprising;

a user interface that is configured to be usable by the patient to select, from the plurality of operational parameters, a selected operational parameter that is to be adjusted by the patient using the pocket controller, and that is configured to input or select an adjustment to the selected operational parameter.

9. The system of claim 8, wherein the implantable medical device is a neurostimulator comprising a source of electrical energy operatively connected to a network of electrodes to deliver a series of electrical pulses to the electrodes for electrically stimulating a portion of the patient'"'"'s nervous system.

10. The system of claim 9, wherein the patient controller comprises a user interface that is usable by the patient to adjust an amplitude of an individual electrical pulse relative to an amplitude of another electrical pulse in the series of electrical pulses, and the user interface of the pocket controller is usable by the patient to adjust a global amplitude of all electrical pulses in the series of electrical pulses.

11. The system of claim 10, wherein the user interface of the pocket controller is not usable by the patient to adjust the amplitude of the individual electrical pulse relative to the amplitude of the another electrical pulse.

12. The system of claim 8, wherein the patient controller comprises a communication module that communicates with the implantable medical device by transmitting signals within a frequency band ranging from about 402 MHz to about 405 MHz.

13. The system of claim 8, wherein the patient controller comprises a rechargeable battery.

14. The system of claim 8, wherein the user interface of the pocket controller comprises:

a first input device that is to be actuated by the patient to input the selected operational parameter selected from the plurality of operational parameters to be adjusted by the patient using the pocket controller, and

a second input device that is to be actuated by the patient to input an adjustment to the selected operational parameter.

15. The system of claim 14, wherein the first input device is to be actuated by the patient to change the selected operational parameter to a different one of the plurality of operational parameters, and the second input device is to be actuated by the patient to adjust the different one of the operational parameters.

16. The system of claim 14, wherein the first input device is to be actuated by the patient to change the selected operational parameter to a different one of the plurality of operational parameters, and the second input device is to be actuated by the patient to adjust the different one of the operational parameters.

17. The system of claim 8, wherein the pocket controller further comprises a display device that displays at least one of:

a status of a battery provided to power the implantable medical device;

a status of a battery provided to power the pocket controller;

an operational status of the implantable medical device; and

information concerning the selected operational parameter.

18. The system of claim 17, wherein the information concerning the selected operational parameter is to be displayed by the display device, and the information concerning the selected operational parameter comprises at least one of:

an amplitude of pulses in a series of electrical pulses to be emitted by the implantable medical device, and a program defining the plurality of operational parameters to be executed by the implantable medical device.

19. The system of claim 8, wherein the pocket controller further comprises a connector for receiving a key ring that is to couple a key to the pocket controller.

20. The system of claim 8, wherein the pocket controller further comprises an input lock that is to be activated by the patient to disable the user interface to minimize unintentional use of the user interface until the input lock is deactivated.

21. The system of claim 8, wherein said programming the implantable medical device with said stimulation program includes determining the number of the plurality of, but less than all of the operational parameters that are adjusted by said pocket programmer.

22. A system for treating a patient, the system comprising:

an implantable electrical stimulation device that is configured to be implanted in the patient and that is configured to execute an electrical stimulation program to be performed on the patient, wherein said electrical stimulation program is governed by a plurality of operational parameters;

a clinician programmer configured for use by a health care provider for programming the implantable medical device with said stimulation program;

a patient controller that is configured to communicate with the implantable electrical stimulation device and is configured to be placed in possession of the patient to allow the patient to adjust the plurality of operational parameters of the program programmed by the clinician programmer while the implantable electrical stimulation device is implanted in the patient, said plurality of operational parameters comprising an amplitude of an individual electrical pulse to be emitted by the implantable electrical stimulation device relative to an amplitude of another electrical pulse to be emitted by the implantable electrical stimulation device; and

a pocket controller that is configured to communicate with the implantable electrical stimulation device and that is configured to be placed in possession of the patient, said pocket controller comprising a smaller form factor than a form factor of the patient controller, wherein said pocket controller is configured to be usable by the patient to adjust a plurality of, but less than all of the operational parameters of the program programmed by the clinician programmer that are adjustable by the patient controller, wherein one of the operational parameters adjustable via the pocket controller comprises a global amplitude of electrical pulses in a series of electrical pulses to be emitted by the implantable electrical stimulation device, said pocket controller further comprising;

a user interface that is configured to be usable by the patient to input an adjustment of each of the plurality of operational parameters,

a communication module and control module that are configured to communicate with the implantable electrical stimulation device for requesting information from the implantable electrical stimulation device about which stimulation programs are currently available in the implantable medical device for use by the patient, and

a display device that is configured to display at least one of a status of a battery provided to power the implantable electrical stimulation device, a status of a battery provided to power the pocket controller, an operational status of the implantable electrical stimulation device, and information concerning one or more of the operational parameters of the stimulation programs that are currently available in the implantable medical device.

23. The system of claim 22, wherein the display device displays the information concerning one or more of the operational parameters, comprising a program defining the plurality of operational parameters selected to be executed by the implantable electrical stimulation device.

24. The system of claim 22, wherein the user interface of the pocket controller is not usable by the patient to adjust the amplitude of the individual electrical pulse relative to the amplitude of the another electrical pulse.

25. The system of claim 22, wherein the patient controller comprises a communication module that communicates with the implantable medical device by transmitting signals within a frequency band ranging from about 402 MHz to about 405 MHz.

26. The system of claim 22, wherein the user interface of the pocket controller comprises:

a first input device that is to be actuated by the patient to change a selected operational parameter out of the plurality of operational parameters to be adjusted by the patient using the pocket controller, and

a second input device that is to be actuated by the patient to input an adjustment to the selected operational parameter.

27. The system of claim 22, wherein said programming the implantable medical device with said stimulation program includes determining the number of the plurality of, but less than all of the operational parameters that are adjusted by said pocket programmer.

28. A method of familiarizing a patient with a programmer for controlling execution of a treatment routine to be performed on the patient using an implanted electrical stimulation device, wherein said treatment routine is governed by a plurality of operational parameters controlling said implanted electrical stimulation device, the method comprising:

providing the patient with a first pocket controller that communicates with a temporary, trial electrical stimulation device supported externally of the patient during a trial period to perform the treatment routine, wherein said trial period is to determine whether the treatment routine performed by the external electrical stimulation device is beneficial to the patient;

in response to a determination that the treatment routine is beneficial to the patient, programming the implanted electrical stimulation device with one or more stimulation programs using the plurality of operational parameters, said programming being performed in a clinical setting by a specially trained personnel;

establishing communication between the first pocket controller and the implanted electrical stimulation device or establishing communication between a second pocket controller, which is substantially-similar to the first pocket controller, and the implanted electrical stimulation device to request information from the implanted electrical stimulation device about which stimulation programs are current available in the stimulation device, said established communication further configured to change a subset of the plurality of the operational parameters of the stimulations programs that have been indicated as being currently available in the stimulation device, wherein said first pocket controller or said second pocket controller used for said establishing step cannot be used by the trained personnel for said programming step; and

establishing communication between a patient controller to be provided to the patient and the implanted electrical stimulation device to change a greater number of the operational parameters than a number of the subset of said operational parameters that are adjustable using the first or second pocket controllers, wherein said patient controller cannot be used by the trained personnel for said programming step.

29. The method of claim 28, wherein the first and second pocket controllers are identical.

30. The method of claim 28, wherein the patient controller comprises a user interface that is usable by the patient to adjust an amplitude of an individual electric pulse emitted by the internal electric stimulation device relative to an amplitude of another electric pulse in a series of electric pulses emitted by the internal electric stimulation device, and the first and second pocket controllers each comprise a limited user interface that is usable by the patient to adjust a global amplitude of all electric pulses in a series of electric pulses.

31. The method of claim 30, wherein the limited user interface is not usable by the patient to adjust the amplitude of the individual electric pulse relative to the amplitude of the another electric pulse.

32. The method of claim 30, wherein said greater number of the operational parameters is established in said step of programming the implanted electrical stimulation device.

33. A method of providing a stimulation therapy for a patient using an implanted electrical stimulation device, said method comprising:

providing specially trained personnel with a clinician controller that communicates directly with the implanted medical device;

establishing communication between the clinician controller and the implanted electrical stimulation device for programming the implanted electrical stimulation device with one or more stimulation programs using the plurality of operational parameters, said programming being performed in a clinical setting by the specially trained personnel;

providing the patient with a portable controller that communicates with the implanted electrical stimulation device;

establishing communication between the portable controller and the implanted electrical stimulation device to change a subset of less than all of the plurality of the operational parameters, wherein said patient controller is used by the patient outside of the clinical setting and cannot be used by the trained personnel for said programming step, such that

said established communication includes the step of requesting information from said implantable medical device that includes information about which stimulation programs are currently available in the implantable medical device for use by the user, and

said portable controller accepting user inputs limited to modifying settings of those stimulation programs that are currently available in the implantable medical device.

34. The method of claim 33, wherein said subset of less than all of the plurality of the operational parameters is established in said step of establishing communication between the clinician controller and the implanted electrical stimulation device for programming the implanted electrical stimulation device.