Generic multi-step therapeutic treatment protocol

• US 7,008,413 B2
• Filed: 06/11/2003
• Issued: 03/07/2006
• Est. Priority Date: 04/30/1999
• Status: Expired due to Fees

• 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:
  US10/459,672
• Publication Number:
  US 20030199854A1
• Time in Patent Office: 1,000 Days
• Field of Search: 607/890.1, 607/891.1, 607 19- 21, 607 30- 31, 607/48, 607/131, 607/151, 607/93, 607/502, 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 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

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

a start delay or start time,

a treatment rate or dose, and

a treatment duration.

2. The computer-readable medium of claim 1, 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.

3. The computer-readable medium of claim 1, 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.

4. The computer-readable medium of claim 1, wherein the at least one treatment step starts executing at a programmed absolute start time.

5. The computer-readable medium of claim 1, comprising further computer-executable instructions for performing a patient-activated bolus while performing the at least one treatment step.

6. The computer-readable medium of claim 5, 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.

7. The computer-readable medium of claim 1, wherein the at least one treatment-step group starts and ends in accordance with an absolute start time and an absolute end time, respectively.

8. The computer-readable medium of claim 1, wherein the at least one treatment-step group starts in accordance with a programmed delay relative to completion of an earlier executed treatment step.

9. The computer-readable medium of claim 1, wherein the at least one treatment step group includes providing treatment at a background rate when no treatment step is actively providing treatment.

10. The computer-readable medium of claim 1, wherein a maximum amount of treatment administered by the at least one treatment-step group is limited by a programmed maximum dosage.

11. The computer-readable medium of claim 1, wherein the treatment-step-group repetition count specifies that the at least one treatment-step group should repeat forever.

12. The computer-readable medium of claim 1, 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.

13. 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 administering at least one activated bolus in accordance with downlinked generic treatment parameters including;

a start delay or start time,

a treatment rate or dose, and

a treatment duration.

14. The system of claim 13, 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.

15. The system of claim 13, 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.

16. The system of claim 13, wherein the at least one treatment step starts executing at a programmed absolute start time.

17. The system of claim 13, further comprising:

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

18. The system of claim 13, further comprising:

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

19. The system of claim 13, wherein the at least one treatment-step group starts and ends in accordance with an absolute start time and an absolute end time, respectively.

20. The system of claim 13, wherein the at least one treatment-step group starts in accordance with a programmed delay relative to completion of an earlier executed treatment step.

21. The system of claim 13, 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.

22. The system of claim 13, wherein a maximum amount of treatment administered by the at least one treatment-step group is limited by a programmed maximum dosage.

23. The system of claim 13, wherein the treatment-step-group repetition count specifies that the at least one treatment-step group should repeat forever.

24. The system of claim 13, 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.