ADVANCED STEP THERAPY DELIVERY FOR AN AMBULATORY INFUSION PUMP AND SYSTEM

• US 20110137239A1
• Filed: 12/04/2009
• Published: 06/09/2011
• Est. Priority Date: 12/04/2009
• Status: Active Grant

• Current Assignee: Smiths Medical ASD, Inc. (Smiths Group International Holdings Ltd.)
• Original Assignee: Smiths Medical ASD, Inc. (Smiths Group International Holdings Ltd.)
• Inventors: DeBelser, David, Sours, David Pardee, Kersch, Michael Wade, Hetchler, Clinton Robert
• Granted Patent: US 8,882,701 B2
• Time in Patent Office: Days
• US Class Current: 604/67
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/168 Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body flow control in general G05D7/00
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/63 for local operation

Abstract

Embodiments relate to systems, methods and devices for delivering a drug or other therapy to a patient with an ambulatory infusion pump configured to provide a series of tolerance-building steps leading up to a plateau delivery rate. The plateau delivery rate is maintained until the prescribed amount of drug or therapy fluid is delivered to the patient. Embodiments of the invention include providing the patient or other user with a mechanism to decrease, or step down, the therapy delivery rate if a tolerance was not achieved at a lower rate, and providing notifications prior to a step up in a dosage delivery rate.

Claims

1. An ambulatory infusion pump comprising:

an infusion therapy delivery mechanism;

a graphical user interface (GUI) configured to receive a plurality of parameters defining a step delivery function, the plurality of parameters comprising an initial rate, a plateau rate, a step duration, a rate increment and a total infusion volume; and

a processor coupled to the therapy delivery mechanism and configured to calculate an initial infusion duration based on at least one of the plurality of parameters and to cause the therapy delivery mechanism to operate based on the step delivery function.

2. The pump of claim 1, wherein the GUI presents an option during operation of the therapy delivery mechanism to increase a delivery rate by an amount of the rate increment.

3. The pump of claim 1, wherein the GUI presents an option during operation of the therapy delivery mechanism to decrease a delivery rate by an amount of the rate increment.

4. The pump of claim 3, wherein the processor is configured to calculate a new infusion duration if the delivery rate is decreased during operation of the therapy delivery mechanism.

5. The pump of claim 3, wherein the delivery rate after the decrease is maintained for a period of time needed for the infusion therapy delivery mechanism to deliver the total infusion volume.

6. The pump of claim 1, wherein the GUI is configured to receive at least one parameter defining a delivery function selected from the group consisting of:

a patient-controlled analgesia (PCA) delivery function, a continuous delivery function, an intermittent delivery function, and a taper delivery function.

7. The pump of claim 1, wherein the step delivery function is for an intravenous immunoglobulin (IVIG) therapy.

8. The pump of claim 1, wherein the GUI is configured to display the initial infusion duration.

9. The pump of claim 1, wherein the processor is configured to calculate a total number of steps in the step delivery function based on at least one of the plurality of parameters.

10. A method of defining a step delivery function for an ambulatory infusion system comprising:

receiving an initial rate, a plateau rate, a step duration, a rate increment and a total infusion volume; and

automatically determining an infusion duration based on at least the initial rate, the plateau rate, the step duration, the rate increment and the total infusion volume.

11. The method of claim 10, further comprising:

receiving a delivery rate reduction request.

12. The method of claim 11, further comprising reducing a current delivery rate by an amount of the rate increment.

13. The method of claim 10, further comprising providing a prompt to enter the initial rate, the plateau rate, the step duration, the rate increment and the total infusion volume.

14. The method of claim 13, wherein receiving further comprises receiving the initial rate, the plateau rate, the step duration, the rate increment and the total infusion volume as user interface inputs.

15. The method of claim 10, further comprising displaying the infusion duration on a graphical user interface.

16. The method of claim 10, further comprising selecting the step delivery function from the group consisting of a patient-controlled analgesia (PCA) delivery function, a continuous delivery function, an intermittent delivery function, a taper delivery function, and a step delivery function.

17. The method of claim 10, further comprising delivering a drug according to the step delivery function.

18. The method of claim 16, wherein delivering a drug comprises delivering an intravenous immunoglobulin (IVIG) drug.

19. An infusion system comprising:

an initial rate setting;

a plateau rate setting;

a step duration setting;

a rate increment setting;

a total infusion volume setting; and

an infusion duration setting that is automatically set according to the initial rate setting, the plateau setting, the step duration setting, the rate increment setting and the total infusion volume setting.

20. The system of claim 19, further comprising an ambulatory infusion pump having a pumping mechanism operable to deliver a drug according to a step function defined by the initial rate setting, the plateau setting, the step duration setting, the rate increment setting, the total infusion volume setting and the infusion duration setting.

21. The system of claim 20, wherein the drug is an intravenous immunoglobulin (IVIG) drug.

22. The system of claim 20, wherein the pump comprises a notification system operable to provide a notification prior to a change in a delivery rate of the drug.