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

• US 10,105,542 B2
• Filed: 01/03/2018
• Issued: 10/23/2018
• 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:
  US15/861,580
• Publication Number:
  US 20180133491A1
• Time in Patent Office: 293 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 method for controlling a nerve-stimulating pulse generator coupled to an implantable lead within a patient with a patient remote, the method comprising:

providing a patient remote capable of alternating between an asleep mode and an awake mode;

transitioning the patient remote from the asleep mode to the awake mode by actuating an activation switch of the patient remote;

wirelessly communicating between the patient remote and the pulse generator when the patient remote is in the awake mode;

wirelessly increasing a stimulation level of the pulse generator when a stimulation-increase switch of the patient remote is actuated for a first period of time; and

setting stimulation of the pulse generator to a last stored stimulation level when the stimulation-increase switch of the patient remote is actuated for a second period of time.

2. The method of claim 1, further comprising wirelessly decreasing the stimulation level of the pulse generator when a stimulation-decrease switch of the patient remote is actuated for the first period of time or storing the stimulation level and turning off stimulation of the pulse generator when the stimulation-decrease switch of the patient remote is actuated for the second period of time.

3. The method of claim 2, further comprising automatically switching the patient remote from the awake mode to the asleep mode after a period of patient remote inactivity, wherein the period of inactivity comprises at least 10 seconds.

4. The method of claim 2, further comprising deactivating the stimulation-increase switch and stimulation-decrease switch of the patient remote when the activation switch of the patient remote is in the asleep mode.

5. The method of claim 2, wherein decreasing a stimulation level of the pulse generator comprises decreasing the stimulation level in increments of at least five percent of a nominal stimulation level, a current stimulation level, or a maximum stimulation level.

6. The method of claim 2, wherein decreasing a stimulation level of the pulse generator comprises decreasing the stimulation level by a percentage of the difference between a nominal stimulation level and a maximum stimulation level.

7. The method of claim 1, further comprising displaying a status of therapy remaining in the pulse generator on the patient remote, wherein the therapy remaining status is based on one or more of charge or voltage remaining in a battery of the pulse generator, or stimulation use parameters by the patient.

8. The method of claim 1, further comprising:

maintaining a stimulation level of the pulse generator until the patient remote is operated to terminate stimulation by the pulse generator.

9. The method of claim 1, wherein increasing a stimulation level of the pulse generator comprises increasing the stimulation level in increments of at least five percent of a nominal stimulation level, a current stimulation level, or a maximum stimulation level.

10. The patient remote of claim 1, further comprising setting a maximum stimulation level according to a comfort level of a patient.

11. The method of claim 1, wherein increasing a stimulation level of the pulse generator comprises increasing the stimulation level by a percentage of the difference between a nominal stimulation level and a maximum stimulation level.