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

• US 10,384,067 B2
• Filed: 05/02/2018
• Issued: 08/20/2019
• 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 R
• Application Number:
  US15/969,706
• Publication Number:
  US 20180243572A1
• Time in Patent Office: 475 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 neurostimulation lead, the patient remote comprising:

a portable housing dimensioned to fit within a single hand of an operator;

circuitry at least partially disposed within the portable housing and configured to wirelessly communicate with the nerve-stimulating pulse generator, wherein the circuitry is configured to send one or more commands to the nerve-stimulating pulse generator to cause the nerve-stimulating pulse generator to operate at particular stimulation levels within an adjustment range, the adjustment range being stored on the circuitry, the adjustment range comprising;

an upper stimulation range that extends from a nominal stimulation setting to a maximum stimulation setting, and

a lower stimulation range that extends from the nominal stimulation setting to a minimum stimulation setting,

wherein the nominal stimulation setting is a stimulation setting configured to provide optimal clinical efficacy of treatment;

a stimulation-increase button coupled with the circuitry and operable so as to wirelessly increase a stimulation level of the nerve-stimulating pulse generator; and

a stimulation-decrease button coupled with the circuitry and operable so as to wirelessly decrease the stimulation level of the nerve-stimulating pulse generator;

wherein the circuitry is configured to send an incremental-adjustment command to the nerve-stimulating pulse generator, the incremental-adjustment command being configured to cause an incremental increase or decrease of the stimulation level of the nerve-stimulating pulse generator by a determined step-size upon operation of the stimulation-increase button or stimulation-decrease button, respectively, and wherein the step-size is determined by the circuitry based on a difference between the nominal stimulation setting of the nerve-stimulating pulse generator and the maximum stimulation setting of the nerve-stimulating pulse generator.

2. The patient remote of claim 1, wherein the maximum stimulation setting is a stimulation setting that is set for the nerve-stimulating pulse generator based on a subjective response from a patient relating to patient comfort.

3. The patient remote of claim 1, wherein the step-size is proportional to the difference.

4. The patient remote of claim 3, wherein the step-size is ⅓

of the difference.

5. The patient remote of claim 3, wherein the circuitry is further configured to adjust the stimulation setting of the nerve-stimulating pulse generator within the lower stimulation range.

6. The patient remote of claim 5, wherein the upper stimulation range and the lower stimulation range have a same magnitude of difference from the nominal stimulation setting, and wherein incremental adjustment of the stimulation level with the patient remote is limited to within the upper and lower stimulation ranges.

7. The patient remote of claim 1, wherein the circuitry is configured such that after the nerve-stimulating pulse generator is set at a first stimulation level, the patient remote does not alter the first stimulation level until the patient remote is operated to terminate or change stimulation by the nerve-stimulating pulse generator.

8. The patient remote of claim 1, wherein the circuitry is further configured to receive a confirmation from the nerve-stimulating pulse generator indicating that an instruction from the patient remote has been executed by the nerve-stimulating pulse generator, and wherein the circuitry is further configured to operate a haptic indicator coupled to the portable housing, the haptic indicator being configured to vibrate in response to receiving the confirmation.

9. The patient remote of claim 1, wherein the circuitry is further configured to receive an indication from the nerve-stimulating pulse generator indicating that the nerve-stimulating pulse generator is in a fault condition, and wherein the circuitry is further configured to operate an automatic fault condition indicator disposed on an exterior surface of the portable housing, the automatic fault condition indicator being configured to provide an alert in response to receiving the indication.

10. The patient remote of claim 1, wherein the circuitry is further configured to receive a battery-status information from the nerve-stimulating pulse generator specifying at least a charge of voltage remaining in a battery, and wherein the circuitry is further configured to operate a therapy-remaining display along an exterior surface of the portable housing, the therapy-remaining display being configured to indicate therapy remaining based on at least the charge of voltage remaining in the battery of the nerve-stimulating pulse generator.

11. The patient remote of claim 10, wherein the therapy-remaining display comprises a light emitting diode having at least two contrasting colors or flashing and non-flashing modes or both to indicate if the nerve-stimulating pulse generator needs re-charging, is charging, or has sufficient charge for at least four days of nominal stimulation.

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

13. The patient remote of claim 1, wherein the circuitry is further configured to receive a current stimulation level from the nerve-stimulating pulse generator, and wherein the circuitry is further configured to operate illumination of a plurality of light emitting diodes on a stimulation-level display, wherein a number of illuminated light emitting diodes indicates a current stimulation level of the nerve-stimulating pulse generator.

14. The patient remote of claim 1, wherein the stimulation-increase button and the stimulation-decrease button are each disposed on a raised region of an exterior surface of the portable housing, and wherein a tactile surface of the stimulation-increase button is larger than a tactile surface of the stimulation-decrease button.

15. The patient remote of claim 1, wherein actuation of the stimulation-increase button incrementally increases the stimulation level up to a maximum of three stimulation levels above the nominal stimulation setting.

16. The patient remote of claim 1, wherein actuation of the stimulation-decrease button incrementally decreases the stimulation level down to a minimum of three stimulation levels below the nominal stimulation setting.

17. The patient remote of claim 1, wherein each step-size is more than 5 percent of the nominal stimulation setting.

18. The patient remote of claim 1, wherein each step-size is more than 5 percent of a current stimulation level.

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