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

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.

What is claimed is: 
     
         1 . A method of adjusting a nerve stimulation level of a nerve-stimulating pulse generator with a patient remote, the method comprising:
 receiving, at the nerve-stimulating pulse generator, a command from the patient remote to adjust a stimulation level within an adjustment range, the adjustment range stored in a memory of the nerve-stimulating pulse generator and 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; and 
   determining with the nerve-stimulating pulse generator a step-size by which the stimulation level is to be adjusted, wherein the step-size is determined 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 method of  claim 1 , wherein the step-size is proportional to the difference. 
     
     
         3 . The method of  claim 1 , wherein the step-size is ⅓ of the difference. 
     
     
         4 . The method of  claim 1 , 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. 
     
     
         5 . The method of  claim 1 , further comprising maintaining a first stimulation level until the patient remote is operated to terminate or change stimulation. 
     
     
         6 . The method of  claim 1 , further comprising:
 receiving an indication from the nerve-stimulating pulse generator indicating that the nerve-stimulating pulse generator is in a fault condition, and   operating an automatic fault condition indicator, the automatic fault condition indicator being configured to provide an alert in response to receiving the indication.   
     
     
         7 . The method of  claim 1 , further comprising:
 receiving 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   operating a haptic indicator, the haptic indicator being configured to vibrate in response to receiving the confirmation.   
     
     
         8 . The method of  claim 1 , further comprising:
 receiving a battery-status information from the nerve-stimulating pulse generator specifying at least a charge of voltage remaining in a battery; and   operating a therapy-remaining display configured to indicate therapy remaining based on at least the charge of voltage remaining in the battery of the nerve-stimulating pulse generator.   
     
     
         9 . The method of  claim 8 , 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. 
     
     
         10 . The method of  claim 9 , wherein the patient remote 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 to 4 days of therapy remaining, and with a flashing amber color to indicate less than 2 days of therapy remaining. 
     
     
         11 . The method of  claim 1 , further comprising wirelessly communicating with the nerve-stimulating pulse generator with a patient-remote circuitry of the patient remote. 
     
     
         12 . The method of  claim 11 , further comprising receiving a current stimulation level from the nerve-stimulating pulse generator, and wherein the patient-remote circuitry is further configured to operate illumination of a plurality of light emitting diodes, wherein a number of illuminated light emitting diodes indicates a current stimulation level of the nerve-stimulating pulse generator. 
     
     
         13 . The method of  claim 11 , wherein receiving at the nerve-stimulating pulse generator a command from the patient remote comprises wirelessly increasing a stimulation level of the nerve-stimulating pulse generator in response to operation of a stimulation-increase button. 
     
     
         14 . The method of  claim 11 , wherein receiving at the nerve-stimulating pulse generator a command from the patient remote comprises wirelessly decreasing a stimulation level of the nerve-stimulating pulse generator in response to operation of a stimulation-decrease button. 
     
     
         15 . The method of  claim 1 , wherein the memory of the nerve-stimulation pulse generator stores one or more pulse programs, plans, or patterns. 
     
     
         16 . A patient remote configured to wirelessly control a nerve-stimulating pulse generator coupled to an implantable 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 housing;   an activation switch disposed within a recessed area of the portable housing and coupled to the circuitry so as to reconfigure the patient remote between an awake mode and an asleep mode;   a stimulation-increase switch disposed on an exterior surface of the portable housing and coupled to the circuitry so as to wirelessly increase a stimulation level of the pulse generator; and   a stimulation-decrease switch disposed on the exterior surface of the portable housing and coupled to the circuitry so as to wirelessly decrease a stimulation level of the pulse generator;   wherein the circuitry is configured such that wherein when the patient remote is in the asleep mode, the stimulation-increase switch and the stimulation-decrease switch are inactivated, wherein when the patient remote is in the awake mode, the circuitry of the patient remote is configured to wirelessly communicate with the pulse generator, and the stimulation level is incrementally adjustable by actuation of the stimulation-increase switch or the stimulation-decrease switch by a predetermined percentage of a maximum stimulation level, a nominal stimulation level, or a current stimulation level.   
     
     
         17 . The patient remote of  claim 16 , wherein the stimulation-increase switch and the stimulation-decrease switch are each disposed on a raised region of the exterior surface of the portable housing, and wherein a tactile surface of the stimulation-increase switch is larger than a tactile surface of the stimulation-decrease switch. 
     
     
         18 . The patient remote of  claim 16 , wherein actuation of the stimulation-increase switch incrementally increases the stimulation level up to four stimulation levels above a nominal stimulation level and actuation of the stimulation-decrease switch incrementally decreases the stimulation level down respectively up to three stimulation levels below the nominal stimulation level. 
     
     
         19 . The patient remote of  claim 16 , 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. 
     
     
         20 . The patient remote of  claim 16 , further comprising a stimulation-level display along on the exterior surface of the portable housing, the patient remote configured to wirelessly communicate with the pulse generator and the stimulation-level display configured to indicate a current stimulation level of the pulse generator after the activation switch of the patient remote is switched from the asleep mode to the awake mode. 
     
     
         21 . The patient remote of  claim 20 , 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. 
     
     
         22 . The patient remote of  claim 20 , 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 with illumination of the first three or four light emitting diodes. 
     
     
         23 . The patient remote of  claim 16 , further comprising a therapy-remaining display along the exterior surface of the portable housing configured to indicate therapy remaining based on at least a charge of voltage remaining in a batter of the pulse generator a stimulation use parameters by the patient. 
     
     
         24 . The patient remote of  claim 23 , 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 pulse generator needs re-charging, is charging, or has sufficient charge for at least four days of nominal stimulation. 
     
     
         25 . The patient remote of  claim 23 , 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. 
     
     
         26 . The patient remote of  claim 16 , 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. 
     
     
         27 . The patient remote of  claim 16 , further comprising a haptic indicator coupled to the portable housing configured to vibrate when a command from the patient remote has been executed by the pulse generator. 
     
     
         28 . The patient remote of  claim 16 , wherein the circuitry is configured such that after the stimulation level of the pulse generator is set, the patient remote maintains the stimulation level until the patient remote is operated to terminate or change stimulation by the pulse generator. 
     
     
         29 . The patient remote of  claim 16 , wherein the patient remote to pair with and communicate only and/or directly with the pulse generator. 
     
     
         30 . The patient remote of  claim 16 , wherein the maximum stimulation level is set according to a comfort level of a patient.