ADVANCED STEP THERAPY DELIVERY FOR AN AMBULATORY INFUSION PUMP AND SYSTEM

• US 20150045770A1
• Filed: 10/28/2014
• Published: 02/12/2015
• 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, Hetchler, Clinton Robert, Sours, David Pardee, Kersch, Michael Wade
• Granted Patent: US 10,016,559 B2
• Time in Patent Office: Days
• US Class Current: 604/506
• 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 for providing step delivery therapy to a patient comprising:

a pump control system configured to control operation of a pumping mechanism; and

a control module configured to relay commands to the pump control system, wherein the control module can be configured to receive a plurality of predefined parameters defining a step delivery therapy profile, the step delivery therapy profile comprising an initial medicament delivery rate followed by one or more stepped changes in the medicament delivery rate, and the control module can be further configured to selectively override the step delivery therapy profile by one of;

(a) holding the medicament delivery rate constant, or

(b) reversing the one or more stepped changes in the medicament delivery rate back to a previous medicament delivery rate,

and the selection of (a) or (b) is based at least in part on a patient'"'"'s monitored condition.

2. The pump of claim 1, wherein the control module is configured to receive the plurality of predefined parameters defining a step delivery therapy profile from at least one external computing system.

3. The pump of claim 2, wherein the plurality of predefined parameters defining a step delivery therapy profile are specific to the patient.

4. The pump of claim 1, wherein the control module is further configured to display on a display screen one of information representing at least a portion of the step delivery therapy profile, a current medicament delivery rate, or a combination thereof.

5. The pump of claim 1, wherein the control module is configured to selectively override the step delivery therapy profile by reversing the one or more stepped changes in the medicament delivery rate back to the initial medicament delivery rate.

6. The pump of claim 5, wherein the initial medicament delivery rate is between 0 and 250 mL/hr.

7. The pump of claim 6, wherein the initial medicament delivery rate is the delivery of a minimal amount of medicament necessary to maintain catheter patency.

8. The pump of claim 1, wherein the control module is further configured to selectively override the step delivery therapy profile by increasing the medicament delivery rate beyond the rate prescribed by the step delivery therapy profile.

9. The pump of claim 1, wherein the pump control system is further configured to automatically adjust at least one of the one or more parameters defining the step delivery therapy profile when the received step delivery therapy profile is overridden.

10. The pump of claim 1, wherein the control module is further configured to provide a notification before a change in the medicament delivery rate is affected.

11. A method of defining a step delivery therapy for an ambulatory infusion pump comprising:

receiving a plurality of predefined parameters defining a step delivery therapy profile, the step delivery therapy profile comprising an initial medicament delivery rate followed by one or more stepped changes in a medicament delivery rate; and

selectively overriding the step delivery therapy profile by one of (a) holding the medicament delivery rate constant, or (b) reversing the one or more stepped changes in the medicament delivery rate back to a previous medicament delivery rate, with selection of (a) or (b) based at least in part on a patient'"'"'s monitored condition.

12. The method of claim 11, wherein the plurality of predefined parameters defining a step delivery therapy profile are received from at least one external computing system.

13. The method of claim 12, wherein the plurality of predefined parameters defining a step delivery therapy profile are specific to the patient.

14. The method of claim 11, further comprising displaying on a display screen of the ambulatory infusion pump one of information representing at least a portion of the step delivery therapy profile, a current medicament delivery rate, and a combination thereof.

15. The method of claim 11, wherein selectively overriding the step delivery therapy profile reverses the one or more stepped changes in the medicament delivery rate back to the initial medicament delivery rate.

16. The method of claim 15, wherein the initial medicament delivery rate is between 0 and 250 mL/hr.

17. The method of claim 11, further comprising selectively overriding the step delivery therapy profile by increasing the medicament delivery rate beyond the rate prescribed by the step delivery therapy profile.

18. The method of claim 11, further comprising to automatically adjusting at least one of the one or more parameters defining the step delivery therapy profile when the received step delivery therapy profile is overridden.

19. The method of claim 11, further comprising providing a notification before a change in the medicament delivery rate is affected.

20. An infusion system for providing step delivery therapy to a patient comprising:

at least one ambulatory infusion pump comprising a pump control system configured to control operation of a pumping mechanism and a control module configured to relay commands to the pump control system;

at least one external computing system in communication with a control module of the at least one ambulatory infusion pump;

wherein the control module is configured to receive from the at least one external computing system a plurality of predefined parameters defining a step delivery therapy profile, the step delivery therapy profile comprising an initial medicament delivery rate followed by one or more stepped changes in the medicament delivery rate; and

wherein the control module is further configured to selectively override the step delivery therapy profile by one of (a) holding the medicament delivery rate constant or (b) reversing the one or more stepped changes in the medicament delivery rate back to a previous medicament delivery rate, with selection of (a) or (b) based in part on the patient'"'"'s condition.