Generic multi-step therapeutic treatment protocol

Abstract

A generic treatment protocol is disclosed for therapeutically treating a patient via an implantable treatment device. Treatment steps can be defined to start and end at absolute times, or can be programmed via telemetry to start a certain amount of time after termination of a previously executed treatment step. Treatment steps have a treatment rate or dose attribute and a duration attribute. Treatment steps may optionally enable patient-activated bolus overlays. Patient-activated rate or dosage adjustments can also optionally be enabled. Repeated-execution treatment-step groups are also provided. Such treatment-step groups can have start and end times, a group duration, and a group total dose, each defined in a manner similar to that for a treatment step. Treatment-step groups include a repetition count, which could be set to a value that causes the group to repeat forever. Single execution treatment steps can, accordingly, be programmed to execute before and/or after a repeated-execution treatment-step group.

1 . A therapeutic treatment device adapted to be implanted within a patient's body, the treatment device including a computer-readable medium having computer-executable instructions for causing a processor to store generic therapeutic treatment protocol parameters to thereby define a specific therapeutic treatment protocol by performing steps comprising: 
 storing at least one user-selectable treatment-step duration and at least one user-selectable treatment rate or dose corresponding, respectively, to a user-selectable number of one or more treatment steps;    storing in response to a downlink at least one user-selectable number indicative of a number of treatment steps to be included in one or more corresponding treatment step groups;    storing at least one treatment-step-group repetition count for at least one of the treatment-step groups; and    storing, for at least one of the treatment-step groups, an absolute start time and an absolute end time.    
   
   
       2 . The treatment-device computer-readable medium of  claim 1 , wherein the absolute start time and the absolute end time are specified in a form indicative of a time-of-day.  
   
   
       3 . The treatment-device computer-readable medium of  claim 1 , further including computer-executable instructions for storing a value for the treatment-step-group repetition count indicative of a finite number of treatment-step-group repetitions.  
   
   
       4 . The treatment-device computer-readable medium of  claim 1 , further including computer-executable instructions for storing at least one treatment-step-group repetition count that indicates that at least one treatment-step group should repeat forever.  
   
   
       5 . The treatment-device computer-readable medium of  claim 1 , further including computer-executable instructions for storing at least one user-selectable treatment-step-group duration for at least one of the treatment-step groups.  
   
   
       6 . The treatment-device computer-readable medium of  claim 1 , further including computer-executable instructions for storing generic treatment protocol parameters defining a series of single-execution treatment steps to be executed before execution of the treatment-step groups.  
   
   
       7 . The treatment-device computer-readable medium of  claim 1 , further including computer-executable instructions for storing generic treatment protocol parameters defining a series of single-execution treatment steps to be executed after execution of the treatment-step groups.  
   
   
       8 . The treatment-device computer-readable medium of  claim 1 , further including computer-executable instructions for storing at least one start delay, specified relative to completion of at least one of the treatment steps, for at least one of the treatment-step groups.  
   
   
       9 . The treatment-device computer-readable medium of  claim 1 , further including computer-executable instructions for storing an indication that a patient-activated bolus is allowed to be overlaid onto at least one of the treatment steps.  
   
   
       10 . The treatment-device computer-readable medium of  claim 1 , further including computer-executable instructions for storing an indication that a patient-activated treatment-rate adjustment is allowed to be overlaid onto at least one of the treatment steps.  
   
   
       11 . The treatment-device computer-readable medium of  claim 1 , further including computer-executable instructions for storing an indication that a physician has disallowed any patient-activated boluses from being overlaid onto at least one of the treatment steps.  
   
   
       12 . The treatment-device computer-readable medium of  claim 1 , further including computer-executable instructions for storing an indication that a physician has disallowed any patient-activated treatment-rate adjustments from being overlaid onto at least one of the treatment steps.  
   
   
       13 . The treatment-device computer-readable medium of  claim 1 , further including computer-executable instructions for storing an indication that the treatment device should, at a predetermined time, switch from a first time-zone representation of time to a second time-zone representation of time based upon expected patient travel from a first time zone to a second time zone.  
   
   
       14 . A therapeutic treatment device adapted to be implanted within a patient's body, the treatment device having a computer-readable medium having computer-executable instructions stored thereon, providing treatment steps and treatment-step groups, the device further comprising input means adapted to receive input from the user for selecting the number, duration and rate or dose of each of said treatment steps; wherein said number is more than one and indicates the number of treatment steps to be included in one or more corresponding treatment-step-groups, and wherein said input means is further adapted to receive input from the user to select a treatment-step-group repetition count and a treatment step group duration.  
   
   
       15 . The treatment device of  claim 14 , wherein said input means is adapted to receive input from the user for selecting the repeated execution of at least one of said one or more treatment-step groups forever.  
   
   
       16 . The treatment device of  claim 14 , wherein said input means is adapted to receive input from the user for selecting the optional execution of a series of single-execution treatment steps before executing a treatment-step group.  
   
   
       17 . The treatment device of  claim 14 , wherein said input means is adapted to receive input from the user to select the start of execution of at least one of the one or more treatment-step groups at a predetermined start time and the end of the execution of said at least one of the one or more treatment-step groups at a predetermined end time.  
   
   
       18 . The treatment device of  claim 14 , wherein said input means is adapted to receive input from the user to select the start of execution of at least one of the one or more treatment-step groups after a corresponding user-selectable start delay relative to completion of execution of one of said one or more treatment steps.  
   
   
       19 . The treatment device of  claim 14 , wherein said input means is adapted to receive input from the user to select a patient-activated bolus to be provided during at least one of the one or more treatment steps.  
   
   
       20 . The treatment device of  claim 14 , wherein said input means is adapted to receive input from the user to select a patient-activated treatment rate adjustment to be provided during at least one of the one or more treatment steps.  
   
   
       21 . The treatment device of  claim 14 , wherein said input means is adapted to receive input from the user to select the execution of at least one of the one or more treatment step groups to start at an absolute start time; and to receive input from the user to select the execution of said at least one or more treatment step groups to end at a corresponding absolute end time.  
   
   
       22 . The treatment device of  claim 14 , wherein said device is an infusion-pump for therapeutically infusing medicaments into a patient's body.  
   
   
       23 . The treatment device of  claim 22 , said input means being adapted to receive input from the user to select at least one of the one or more infusion steps to allow a bolus activated by the patient via telemetry to be overlaid onto the at least one of the one or more infusion steps.  
   
   
       24 . The treatment device of  claim 22 , said input means being adapted to receive input from the user to select at least one of the one or more infusion steps to allow a rate adjustment activated by the patient via telemetry to be overlaid onto the at least one of the one or more infusion steps.  
   
   
       25 . The treatment device of  claim 14 , wherein said device is a nerve stimulator for therapeutically stimulating the nervous system of a patient via an electric nerve stimulator implanted within the patient's body.  
   
   
       26 . The treatment device of  claim 25 , said input means being adapted to receive input from the user to select at least one of the one or more stimulation steps to allow a bolus activated by the patient via telemetry to be overlaid onto the at least one of the one or more stimulation steps.  
   
   
       27 . The treatment device of  claim 25 , said input means being adapted to receive input from the user to select at least one of the one or more stimulation steps to allow a rate adjustment activated by the patient via telemetry to be overlaid onto the at least one of the one or more stimulation steps.  
   
   
       28 . A therapy treatment device configured to be implanted within a patient's body, the therapy treatment device comprising: 
 a housing;    a processor mounted in the housing an antenna in communication with the processor; and    a memory including computer executable instructions for causing the processor to perform the steps:    (a) receiving a downlink containing a treatment protocol;    (b) storing in the memory at least one user-selectable treatment-step duration and at least one user-selectable treatment rate or dose corresponding, respectively, to a user-selectable number of one or more treatment steps;    (b) storing in the memory least one user-selectable number indicative of a number of treatment steps to be included in one or more corresponding treatment step groups; and    (c) storing at least one treatment-step-group repetition count for at least one of the treatment-step groups.    
   
   
       29 . The device of  claim 28 , wherein the protocol received in (a) is a complex continuous mode.