Generic multi-step therapeutic treatment protocol

• US 20030199854A1
• Filed: 06/11/2003
• Published: 10/23/2003
• Est. Priority Date: 04/30/1999
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Ullestad, David C., Kovach, Peter J., Lang, Craig R.
• Granted Patent: US 7,008,413 B2
• Time in Patent Office: Days
• US Class Current: 604/890.1
• 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 therapeutic treatment device adapted to be implanted within a patient'"'"'s body, the treatment device having a computer-readable medium, the computer readable medium having computer-executable instructions for storing 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 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 having further 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 having further 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 having further 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 having further 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 having further 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 having further 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 The treatment-device computer-readable medium of claim 1 having further 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 having further 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 having further 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 having further 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 having further 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 computer-readable medium containing computer-executable instructions that cause a human-implantable therapeutic treatment device to perform a specific therapeutic treatment protocol by performing steps comprising:

performing at least one treatment step that is defined, at least in part, by generic treatment parameters including a treatment rate or dose and a treatment duration, which have been downlinked to the treatment device;

performing at least one treatment-step group a number of times that is specified by a treatment-step-group repetition count that has been downlinked to the treatment device; and

performing at least one bolus in accordance with downlinked generic treatment parameters including;

a start delay or start time,

a treatment rate or dose, and

a treatment duration.

15. The computer-readable medium of claim 14, wherein the at least one treatment step starts executing after a programmed delay relative to when the generic treatment protocol parameters are downlinked to the implantable device.

16. The computer-readable medium of claim 14, wherein the at least one treatment step is programmed to start executing after a predetermined amount of time elapses following completion of a preceding treatment step.

17. The computer-readable medium of claim 14, wherein the at least one treatment step starts executing at a programmed absolute start time.

18. The computer-readable medium of claim 14, comprising further computer-executable instructions for performing a patient-activated bolus while performing the at least one treatment step.

19. The computer-readable medium of claim 18, comprising further computer-executable instructions for disallowing an attempted patient-activated rate adjustment that would exceed a programmed maximum rate adjustment for the at least one treatment step.

20. The computer-readable medium of claim 14, wherein the at least one treatment-step group starts and ends in accordance with an absolute start time and an absolute end time, respectively.

21. The computer-readable medium of claim 14, wherein the at least one treatment-step group starts in accordance with a programmed delay relative to completion of an earlier executed treatment step.

22. The computer-readable medium of claim 14, wherein the at least one treatment step group includes providing treatment at a background treatment while no treatment step is actively providing treatment.

23. The computer-readable medium of claim 14, wherein a maximum amount of treatment administered by the at least one treatment-step group is limited by a programmed maximum dosage.

24. The computer-readable medium of claim 14, wherein the treatment-step-group repetition count specifies that the at least one treatment-step group should repeat forever.

25. The computer-readable medium of claim 14, wherein the bolus includes a programmed priority that specifies that the bolus has a priority selected from the group consisting of:

a low-priority patient-activated bolus that takes precedence over treatment steps that specifically allow themselves to be overlaid by low-priority boluses, and

a high-priority physician-activated bolus that takes precedence over treatment steps.

26. A system for causing a human-implantable therapeutic treatment device to perform a specific therapeutic treatment protocol, the system comprising:

means for performing at least one treatment step that is defined, at least in part, by generic treatment parameters including a treatment rate or dose and a treatment duration, which have been downlinked to the treatment device;

means for performing at least one treatment-step group a number of times that is specified by a treatment-step-group repetition count that has been downlinked to the treatment device; and

means for performing at least one bolus in accordance with downlinked generic treatment parameters including;

a start delay or start time,

a treatment rate or dose, and

a treatment duration.

27. The system of claim 26, wherein the at least one treatment step starts executing after a programmed delay relative to when the generic treatment protocol parameters are downlinked to the implantable device.

28. The system of claim 26, wherein the at least one treatment step is programmed to start executing after a predetermined amount of time elapses following completion of a preceding treatment step.

29. The system of claim 26, wherein the at least one treatment step starts executing at a programmed absolute start time.

30. The system of claim 26, further comprising:

means for performing a patient-activated bolus while performing the at least one treatment step.

31. The system of claim 30, further comprising:

disallowing an attempted patient-activated rate adjustment that would exceed a programmed maximum rate adjustment for the at least one treatment step.

32. The system of claim 26, wherein the at least one treatment-step group starts and ends in accordance with an absolute start time and an absolute end time, respectively.

33. The system of claim 26, wherein the at least one treatment-step group starts in accordance with a programmed delay relative to completion of an earlier executed treatment step.

34. The system of claim 26, wherein the at least one treatment step group includes means for providing treatment at a background treatment while no treatment step is actively providing treatment.

35. The system of claim 26, wherein a maximum amount of treatment administered by the at least one treatment-step group is limited by a programmed maximum dosage.

36. The system of claim 26, wherein the treatment-step-group repetition count specifies that the at least one treatment-step group should repeat forever.

37. The system of claim 26, wherein the bolus includes a programmed priority that specifies that the bolus has a priority selected from the group consisting of:

a low-priority patient-activated bolus that takes precedence over treatment steps that specifically allow themselves to be overlaid by low-priority boluses, and

a high-priority physician-activated bolus that takes precedence over treatment steps.