Patient remote and associated methods of use with a nerve stimulation system

• US 9,895,546 B2
• Filed: 01/11/2016
• Issued: 02/20/2018
• Est. Priority Date: 01/09/2015
• Status: Active Grant

• Current Assignee: Axonics, Inc.
• Original Assignee: Axonics Modulation Technologies, Inc.
• Inventors: Jiang, Guangqiang, Woock, John, Schroeder, Dennis, Schmid, Eric
• Primary Examiner(s): Evanisko, George
• Application Number:
  US14/992,777
• Publication Number:
  US 20160199659A1
• Time in Patent Office: 771 Days
• CPC Class Codes: A61N 1/36057 adapted for stimulating afferent nerves
• CPC Class Codes: A61N 1/36128 Control systems
• CPC Class Codes: A61N 1/36132 using patient feedback
• CPC Class Codes: A61N 1/36142 for improving safety
• CPC Class Codes: A61N 1/36146 specified by the stimulation parameters
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer
• CPC Class Codes: A61N 1/37241 providing test stimulations
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means

Abstract

A neurostimulation system having an external or an implantable pulse generator programmed to innervate a specific nerve or group of nerves in a patient through an electrode as a mode of treatment, having a patient remote that wirelessly communicates with the pulse generator to increase stimulation, decrease stimulation, and provide indications to a patient regarding the status of the neurostimulation system. The patient remote can allow for adjustment of stimulation power within a clinically effective range and for turning on and turning off the pulse generator. The patient remote and neurostimulation system can also store a stimulation level when the pulse generator is turned off and automatically restore the pulse generator to the stored stimulation level when the pulse generator is turned on.

Claims

1. A patient remote configured to wirelessly control a nerve-stimulating pulse generator coupled to an implantable lead in a patient, the patient remote comprising:

a portable housing configured to be operable by a single hand of an operator;

circuitry disposed within the portable housing, the circuitry configured to wirelessly communicate with the pulse generator;

an activation button disposed on an exterior surface of the portable housing and coupled to the circuitry, wherein the circuitry is further configured to reconfigure the patient remote between an awake mode and an asleep mode when the activation button is actuated; and

a stimulation-increase button disposed on the exterior surface of the portable housing, the stimulation-increase button coupled to the circuitry, wherein when the stimulation-increase button is actuated the circuitry is further configured to wirelessly send instruction signals to the pulse generator to increase a stimulation level of the pulse generator;

wherein when the patient remote is in the awake mode, actuation of the stimulation-increase button for a first period of time causes the circuitry to communicate the instruction signals to the pulse generator to increase the stimulation level of the pulse generator, and actuation of the stimulation-increase button for a second period of time causes the circuitry to communicate the instruction signals to the pulse generator to restore the pulse generator to a last stored stimulation level.

2. The patient remote of claim 1, wherein first period of time comprises a period of time less than a threshold period and the second period of time comprises a period of time greater than the threshold, wherein actuation of the stimulation-increase button for the second period of time ramps the stimulation level to the last stored stimulation level, and wherein the threshold period is three seconds or more.

3. The patient remote of claim 1, further comprising a memory element coupled to the circuitry, and further comprising a stimulation-decrease button disposed on the exterior surface of the portable housing and coupled to the circuitry so as to wirelessly decrease the stimulation level of the pulse generator, wherein when the patient remote is in the awake mode, actuation of the stimulation-decrease button for the first period of time decreases the stimulation level, and actuation of the stimulation-decrease button for the second period of time stores the stimulation level in the memory element for subsequent use as the stored stimulation level and turns off the stimulation by the pulse generator.

4. The patient remote of claim 3, wherein the circuitry is configured so that repeated actuation of the stimulation-increase button can incrementally increase the stimulation level no more than four stimulation levels above a nominal stimulation level and repeated actuation of the stimulation-decrease button can incrementally decrease the stimulation level down respectively no more than three stimulation levels below the nominal stimulation level.

5. The patient remote of claim 3, wherein each stimulation level increase or stimulation level decrease of the pulse generator comprises more than 5 percent of a nominal stimulation level or a current stimulation level.

6. The patient remote of claim 1, further comprising a stimulation-level display disposed on the exterior surface of the portable housing, the stimulation-level display and circuitry configured to indicate a current stimulation level of the pulse generator when the activation button of the patient remote is switched from the asleep mode to the awake mode.

7. The patient remote of claim 6, wherein the stimulation-level display comprises a plurality of light emitting diodes, wherein a number of illuminated light emitting diodes indicates the current stimulation level of the pulse generator.

8. The patient remote of claim 6, wherein the stimulation-level display comprises at least seven light emitting diodes of at least three or four differing sizes, wherein a nominal stimulation level corresponds to illumination of the first three or four light emitting diodes.

9. The patient remote of claim 1, further comprising a therapy-remaining display on the exterior surface of the portable housing, the therapy-remaining display and circuitry configured to indicate therapy remaining status of the pulse generator based on at least a charge or voltage remaining in a battery of the pulse generator and stimulation use by the patient.

10. The patient remote of claim 9, wherein the therapy-remaining display comprises a light emitting diode having a plurality of contrasting display modes, the display modes comprising a plurality of colors or flashing and non-flashing illumination or both and sufficient to indicate if the pulse generator needs re-charging, is charging, or has sufficient charge for at least a threshold number of days of stimulation.

11. The patient remote of claim 10, wherein the therapy-remaining display light emitting diode illuminates with a non-flashing green color to indicate at least 4 days of therapy remaining, illuminates with a non-flashing amber color to indicate 2-4 days of therapy remaining, and illuminates with a flashing amber color to indicate less than 2 days of therapy remaining.

12. The patient remote of claim 1, further comprising an automatic fault condition indicator disposed on the exterior surface of the portable housing configured to provide an alert if the pulse generator is in a fault condition.

13. The patient remote of claim 1, further comprising a haptic indicator coupled to the portable housing and configured to vibrate when a command from the patient remote has been executed by the pulse generator.

14. The patient remote of claim 1, wherein the patient remote is configured to wirelessly control either an external or implantable nerve-stimulating pulse generator and wherein the external or implantable nerve-stimulating pulse generator includes an implantable lead that comprises at least one electrode configured for insertion into a foramen of a sacrum near a sacral nerve.

15. The patient remote of claim 1, wherein the circuitry is configured to send instruction signals such that the stimulation level of the pulse generator is incrementally increased or decreased by a predetermined amount of a maximum stimulation level, a nominal stimulation level, or a current stimulation level of the pulse generator.

16. The patient remote of claim 15, wherein the predetermined amount is a percentage between five and twenty percent of:

a maximum stimulation level, a nominal stimulation level, or a current stimulation level of the pulse generator.

17. The patient remote of claim 15, wherein the maximum stimulation level is set according to incremental step-sizes, corresponding to a comfort level of a patient.

18. The patient remote of claim 1, wherein the patient remote maintains the stimulation level after the stimulation level of the pulse generator is set, until the patient remote is operated by the operator to terminate or change stimulation by the pulse generator.

19. The patient remote of claim 1, wherein the patient remote circuitry is configured to pair with and communicate only and/or directly with the pulse generator.