Generic multi-step therapeutic treatment protocol

• US 6,579,280 B1
• Filed: 04/30/1999
• Issued: 06/17/2003
• Est. Priority Date: 04/30/1999
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Ullestad, David C., Kovach, Peter J., Lang, Craig R.
• Primary Examiner(s): Jastrzab, Jeffrey R.
• Application Number:
  US09/302,613
• Time in Patent Office: 1,509 Days
• Field of Search: 604/890--89, 604/19-21, 604/30-31, 604/48, 604/131, 604/151, 604/93, 604/502, 607/45, 607/72, 607/59, 607/60
• US Class Current: 604/891.1
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 20/30 relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising

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.

Claims

1. A method of programming a human-implantable therapeutic treatment device to perform a specific treatment protocol by downlinking a plurality of generic treatment protocol parameters to the device, the method comprising the steps of:

downlinking 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, wherein the one or more treatment steps are defined, at least in part, by at least one treatment-step duration and at least one treatment rate or dose;

downlinking at least one user-selectable number that is greater than 1 and that indicates a number of treatment steps to be included in one or more corresponding treatment-step groups;

downlinking at least one treatment-step-group repetition count for at least one of the treatment-step groups having more than one treatment step, the treatment-step-group repetition count specifying how many times the at least one of the treatment-step groups should be performed and the treatment-step-group repetition count being capable of specifying a finite number of treatment-step-group repetitions; and

downlinking at least one user-selectable treatment-step-group duration for at least one of the treatment-step groups having more than one treatment step.

2. The method of claim 1, wherein the step of downlinking at least one treatment-step-group repetition count for at least one of the treatment-step groups further comprises the step of downlinking at least one treatment-step-group repetition count that indicates that at least one treatment-step group should repeat forever.

3. The method of claim 1, wherein the step of downlinking at least one user-selectable treatment-step duration and at least one user-selectable treatment rate or dose for a respective user-selectable number of one or more treatment steps defines a series of single-execution treatment steps to be executed before execution of the treatment-step groups.

4. The method of claim 1, wherein the step of downlinking at least one user-selectable treatment-step duration and at least one user-selectable treatment rate or dose for a respective user-selectable number of one or more treatment steps defines a series of single-execution treatment steps to be executed after execution of the treatment-step groups.

5. The method of claim 1, further comprising the step of downlinking, for at least one of the treatment-step groups, an absolute start time and an absolute end time, wherein the absolute start time and the absolute end time are specified in a form indicative of a time-of-day rather than in a form indicative of a delay from a downlinking step.

6. The method of claim 1, further comprising the step of:

downlinking 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.

7. The method of claim 1, further comprising the step of downlinking an indication that a patient-activated bolus is allowed to be overlaid onto at least one of the treatment steps.

8. The method of claim 1, further comprising the step of downlinking an indication that a patient-activated treatment-rate adjustment is allowed to be overlaid onto at least one of the treatment steps.

9. The method of claim 1, further comprising the step of downlinking an indication that a physician has disallowed any patient-activated boluses from being overlaid onto at least one of the treatment steps.

10. The method of claim 1, further comprising the step of downlinking an indication that a physician has disallowed any patient-activated treatment-rate adjustments from being overlaid onto at least one of the treatment steps.

11. The method of claim 1, further comprising the step of downlinking 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.

12. A method of programming a human-implantable therapeutic treatment device to perform a specific treatment protocol by storing, on a computer-readable medium of the device, a plurality of generic treatment protocol parameters, the method comprising the steps of:

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, wherein the one or more treatment steps are defined, at least in part, by at least one treatment-step duration and at least one treatment rate or dose;

storing at least one user-selectable number that is greater than 1 and that indicates 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 having more than one treatment step, the treatment-step-group repetition count specifying how many times the at least one of the treatment-step group should be performed; and

storing, for at least one of the treatment-step groups, an absolute start time and an absolute end time.

13. The method of claim 12, further comprising the step of storing a value for the treatment-step-group repetition count indicative of a finite number of treatment-step-group repetitions.

14. The method of claim 12 further comprising the step of storing at least one treatment-step-group repetition count that indicates that at least one treatment-step group should repeat forever.

15. The method of claim 12 further comprising the step of storing at least one user-selectable treatment-step-group duration for at least one of the treatment-step groups.

16. The method of claim 12 further comprising the step of storing generic treatment protocol parameters defining a series of single-execution treatment steps to be executed before execution of the treatment-step groups.

17. The method of claim 12 further comprising the step of storing generic treatment protocol parameters defining a series of single-execution treatment steps to be executed after execution of the treatment-step groups.

18. The method of claim 12 further comprising the step of 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.

19. The method of claim 12 further comprising the step of storing an indication that a patient-activated bolus is allowed to be overlaid onto at least one of the treatment steps.

20. The method of claim 12 further comprising the step of storing an indication that a patient-activated treatment-rate adjustment is allowed to be overlaid onto at least one of the treatment steps.

21. The method of claim 12 further comprising the step of storing an indication that a physician has disallowed any patient-activated boluses from being overlaid onto at least one of the treatment steps.

22. The method of claim 12 further comprising the step of 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.

23. The method of claim 12 further comprising the step of 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.

24. The method of claim 12 wherein the absolute start time and the absolute end time are specified in a form indicative of a time-of-day.