Systems and methods for managing and delivering patient therapy through electronic drug delivery systems

• US 8,771,251 B2
• Filed: 12/16/2010
• Issued: 07/08/2014
• Est. Priority Date: 12/17/2009
• Status: Active Grant

• Current Assignee: ICU Medical Incorporated
• Original Assignee: Hospira Incorporated (Pfizer Inc.)
• Inventors: Wehba, Steven R., Thornley, John Harrison, Watt, Joanne Marie, Martin, Carol Dian, Willey, Suzanne, Ruchti, Timothy Lewis, Dharwad, Harsh
• Primary Examiner(s): Berdichevsky, Aarti B
• Assistant Examiner(s): OSINSKI, BRADLEY JAMES
• Application Number:
  US12/970,777
• Publication Number:
  US 20110152830A1
• Time in Patent Office: 1,300 Days
• Field of Search: 604/504, 604/503, 604/890.1, 604 65- 67, 702/2, 702/3
• US Class Current: 604/504
• CPC Class Codes: A61M 2205/35 Communication
• CPC Class Codes: A61M 2205/3507 with implanted devices, e.g. external control
• CPC Class Codes: A61M 2205/3546 Range
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3576 with non implanted data transmission devices, e.g. using external transmitter or receiver
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 50/50 for simulation or modelling of medical disorders

Abstract

In example methods and systems described, a medical device can store information locally and in a separate database on a server, for example. If the device fails, or a patient is moved to a second device, information may be transferred to the second device such that the second device can resume a complex therapy at a point where the initial medical device left off. The data necessary to restart the complex therapy system may include certain underlying patient-specific parameters according to a model capturing the patient'"'"'s physiological response to the medication in question. As a result, it is not necessary for the second device to restart the complex therapy or regress to an initial set of baseline assumptions.

Claims

1. A method for managing and delivering patient therapy through electronic drug delivery systems, the method comprising:

a first electronic drug delivery system that is connected to a patient receiving a patient identifier that corresponds to the patient;

the first electronic drug delivery system estimating underlying patient-specific control variables based on (i) a therapy provided for a patient and (ii) an observed patient-specific response to the therapy, wherein the underlying patient-specific control variables include values of parameters for an algorithm executed over time to determine dosages;

based on (i) the estimated underlying patient-specific control variables, (ii) the observed patient-specific response to the therapy, and (iii) a therapy objective, the first electronic drug delivery system providing an updated therapy for the patient based on updated underlying patient-specific control variables so as to adapt the therapy to the patient;

the first electronic drug delivery system transferring to a remote system a record of the updated therapy provided for the patient and the updated underlying patient-specific control variables;

upon connecting a second electronic drug delivery system to the patient, the second electronic drug delivery system receiving the patient identifier;

the second electronic drug delivery system communicating with the remote system to access the record of the updated therapy and the updated underlying patient-specific control variables associated with the patient identifier;

determining a time that therapy was discontinued by the first electronic drug delivery system and based on the time an amount at which to adjust the therapy being provided; and

adjusting the record of the updated therapy to take into account the amount at which to adjust the therapy that will be provided by the second electronic drug delivery system.

2. The method of claim 1, wherein the first electronic drug delivery system is an infusion system.

3. The method of claim 1, wherein the underlying patient-specific control variables are selected from a group consisting of insulin sensitivity, glomerular filtration rate (GFR), basal infusion rate, multiplication factors, insulin clearance, insulin utilization constants, saturation terms, drug sensitivity, renal function, and drug clearance rates.

4. The method of claim 1, further comprising the first electronic drug delivery system transferring to the remote system the record of the updated therapy provided for the patient and the estimated underlying patient-specific control variables on a periodic basis.

5. The method of claim 1, further comprising the first electronic drug delivery system transferring to the remote system the record of the updated therapy provided for the patient and the estimated underlying patient-specific control variables at least at each instance of a change in one of the estimated underlying patient-specific control variables.

6. The method of claim 1, further comprising receiving a stop command at the first electronic drug delivery system that indicates to discontinue therapy to the patient and responsively transferring current estimated underlying patient-specific control variables and the record of the updated therapy to the remote system prior to the first electronic drug delivery system being disconnected from the patient.

7. The method of claim 1, further comprising the second electronic drug delivery system receiving the record of therapy and the updated underlying patient-specific control variables associated with the patient identifier from the remote system and continuing the therapy for the patient at a point where the therapy was previously discontinued by the first electronic drug delivery system.

8. The method of claim 1, wherein the first electronic drug delivery system wirelessly transfers to the remote system the record of the updated therapy provided for the patient and the estimated underlying patient-specific control variables.

9. The method of claim 1, further comprising removing therapy authorization from the first electronic drug delivery system after the first electronic drug delivery system transfers to the remote system the record of the updated therapy provided for the patient and the updated underlying patient-specific control variables.

10. The method of claim 1, further comprising the first electronic drug delivery system storing (i) the record of the updated therapy provided for the patient and (ii) the estimated underlying patient-specific control variables on a periodic basis.

11. The method of claim 1, wherein the therapy provided for the patient is based on a function in the form of I_t=ƒ

(t, g_t, Ĩ

_t-1, θ

_t, G), where t is the time, I_t is a calculated insulin dose at time t, Ĩ

_t-1 is a delivered insulin dose over a previous time period, g_t is a glucose measurement at time t, θ

_t, is a vector of estimated underlying patient-specific control variables, and G is a set of target glucose concentrations.

12. The method of claim 1, wherein the therapy provided for the patient includes dosing of anti-coagulants including unfractionated heparin, and wherein the observed patient-specific response to the therapy includes an anticoagulation effect of unfractionated heparin monitored via activated partial thromboplastin time (aPTT).

13. The method of claim 12, wherein the updated therapy includes adjustments to a dose of unfractionated heparin to achieve a target clotting time based on observed and targeted aPTT.

14. The method of claim 12, wherein the underlying patient-specific control variables are selected from a group consisting of heparin infusion updates, a time for a next aPTT reading, a drug sensitivity to heparin, or a level of saturable mechanism of elimination of heparin.

15. The system of claim 1, wherein the first drug delivery system wirelessly transfers to the remote system the record of the updated therapy provided for the patient and the estimated underlying patient-specific control variables.

16. A system for managing and delivering patient therapy through drug delivery systems, the system comprising:

a first drug delivery system connected to a patient and receiving a patient identifier that corresponds to the patient, and based on (i) estimated underlying patient-specific control variables, (ii) an observed patient-specific response to the therapy, and (iii) a therapy objective, the first drug delivery system providing an updated therapy for the patient based on updated underlying patient-specific control variables so as to adapt the therapy to the patient, wherein the underlying patient-specific control variables include values of parameters for an algorithm executed over time to determine dosages, and the first drug delivery system transferring to a remote system a record of the updated therapy provided for the patient and the updated underlying patient-specific control variables; and

a second drug delivery system receiving the patient identifier and communicating with the remote system to access the record of the updated therapy and the updated underlying patient-specific control variables associated with the patient identifier, wherein the second drug delivery system is further configured to determine a time that therapy was discontinued by the first electronic drug delivery system and based on the time an amount at which to adjust the therapy being provided, and to adjust the record of the updated therapy to take into account the amount at which to adjust the therapy that will be provided by the second electronic drug delivery system.

17. The system of claim 16, wherein the first drug delivery system and the second drug delivery system are infusion systems.

18. The system of claim 17, wherein the second drug delivery system receives the record of therapy and the updated underlying patient-specific control variables associated with the patient identifier from the remote system and continues the therapy for the patient at a point where the therapy was previously discontinued by the first drug delivery system.

19. A computer readable medium having stored therein instructions executable by a computing device to cause the computing device to perform the functions of:

receiving from a first electronic drug delivery system a record of estimated underlying patient-specific control variables for a patient, the underlying patient-specific control variables being based on (i) a therapy provided for a patient and (ii) an observed patient-specific response to the therapy, wherein the underlying patient-specific control variables include values of parameters for an algorithm executed over time to determine dosages;

receiving from the first electronic drug delivery system an updated therapy provided for the patient based on updated underlying patient-specific control variables so as to adapt the therapy to the patient, the updated therapy being based on (i) the estimated underlying patient-specific control variables, (ii) the observed patient-specific response to the therapy, and (iii) a therapy objective;

transferring to a second electronic drug delivery system a record of the updated therapy provided for the patient and the updated underlying patient-specific control variables associated with the patient;

determining a time that therapy was discontinued by the first electronic drug delivery system and based on the time an amount at which to adjust the therapy being provided; and

adjusting the record of the updated therapy to take into account the amount at which to adjust the therapy that will be provided by the second electronic drug delivery system.