Programmable insulin pump

• US 8,346,399 B2
• Filed: 12/20/2004
• Issued: 01/01/2013
• Est. Priority Date: 02/28/2002
• Status: Active Grant

• Current Assignee: Tandem Diabetes Care Incorporated
• Original Assignee: Tandem Diabetes Care Incorporated
• Inventors: Blomquist, Michael L.
• Primary Examiner(s): Ali, Mohammad
• Assistant Examiner(s): Norton, Jennifer L
• Application Number:
  US11/018,706
• Publication Number:
  US 20050143864A1
• Time in Patent Office: 2,934 Days
• Field of Search: 600/504, 600/890.1, 600/892.1, 600/66, 600/67, 600/118, 600/131, 700/282
• US Class Current: 700/282
• CPC Class Codes: A61M 2005/1405 Patient controlled analgesia [PCA]
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/60 for the operation of medical equipment or devices
• CPC Class Codes: G16H 40/63 for local operation

Abstract

An apparatus for delivering a bolus of a medical agent to a patient. The apparatus comprises a pump mechanism, a data input device, and a processor in data communication with the keypad and arranged to control the pump mechanism. The processor is programmed to receive data specifying a bolus amount through the data port, receive data regarding duration through the data port, receive a percentage through the data port, the percentage defining a portion of the bolus amount to deliver immediately upon executing a deliver command and a remainder of the bolus amount to deliver over the duration upon executing a deliver command, and execute the deliver command thereby controlling the pump mechanism to deliver the bolus. Also a method of temporarily adjusting the delivery rate of an infusion pump. The infusion pump is programmed to deliver a basal rate. The method comprises prompting a user to select whether to enter the temporary rate as a percent of the current delivery rate or as a new delivery rate; entering into the pump a period of time having a beginning and an end; entering into the pump a temporary basal rate; and delivering the therapeutic agent at a delivery rate substantially equal to the temporary basal rate during the period of time.

Claims

1. A method of delivering a meal bolus or a remedial bolus of therapeutic agent from a pump based on a measured characteristic of the body of the user, the meal bolus being given in anticipation of a future condition, the remedial bolus being given to correct an already-existing condition, the measured characteristic having an acceptable range, and the pump being a user-controlled programmable medical infusion pump having a keypad, the method comprising:

measuring the characteristic of the body and determining whether the measured characteristic is within the acceptable range or not;

delivering a meal bolus, if the measured characteristic is inside of the acceptable range, by;

programming a desired bolus amount into the pump,

programming a desired duration of bolus delivery into the pump, and

programming a percentage into the pump by programming a single unitless value, the percentage defining a portion of the bolus amount to deliver upon executing a deliver command and a remainder of the bolus amount to deliver over the duration upon executing a deliver command;

delivering a remedial bolus, if the measured characteristic is outside of the acceptable range, by;

programming a unit measurement of the measured characteristic,

displaying an average correction factor, the average correction factor being the amount of change of the characteristic of the body per each unit of delivered therapeutic agent on average for a predetermined amount of time prior to the current time,

programming a correction factor based on the average correction factor,

programming a duration of time over which the therapeutic agent remains in the body of the user, and

programming a desired bolus amount into the pump;

calculating a residual bolus value, the residual bolus value defining an estimated amount of any previously-delivered bolus still active in a user;

calculating and displaying an adjusted bolus amount based on a difference between the desired bolus amount and the residual bolus value prior to executing the deliver command such that a safe amount of therapeutic agent is delivered; and

executing the deliver command.

2. The method of claim 1 wherein programming a percentage into the pump includes entering into the pump the portion of the bolus amount to deliver upon executing a deliver command.

3. The method of claim 1 wherein programming a percentage into the pump includes entering into the pump the remainder of the bolus amount to deliver over the duration upon executing the deliver command.

4. The method of claim 1 wherein executing the deliver command causes the pump to begin delivery of the bolus, the bolus being insulin.

5. The method of claim 4 further comprising delivering a basal, wherein executing the deliver command causes the pump to begin delivery of the bolus, the bolus being in addition to the basal.

10. The method of claim 1 wherein the step of delivering a remedial bolus can be conducted in combination with the step of delivering a meal bolus.

11. The method of claim 1 wherein delivering a remedial bolus further comprises programming an amount to adjust the level of the characteristic in units of the unit measurement and calculating a recommended remedial bolus amount based on the quotient of the amount to adjust the level of the characteristic and the correction factor, and programming the desired bolus amount further comprises setting the desired bolus amount equal to the recommended remedial bolus amount.

12. The method of claim 11 further comprising adjusting the recommended remedial bolus amount.

6. An apparatus for delivering a meal bolus or a remedial bolus of a medical agent to a patient based on a measured characteristic of the body of the patient, the meal bolus being given in anticipation of a future condition, the remedial bolus being given to correct an already-existing condition, the measured characteristic having an acceptable range, the apparatus comprising:

a pump mechanism;

a patient-controlled data input device; and

a processor in data communication with the keypad and arranged to control the pump mechanism, the processor being programmed to receive data specifying the desired delivery of a meal bolus if the measured characteristic is inside of the acceptable range through the data port, receive data specifying a desired bolus amount through the data port, receive data regarding desired duration through the data port, receive a percentage through the data port, the percentage being a single unitless value and defining a portion of the bolus amount to deliver upon executing a deliver command and a remainder of the bolus amount to deliver over the duration upon executing a deliver command, receive data specifying the desired delivery of a remedial bolus if the measured characteristic is outside of the acceptable range through the data port, receive data specifying a unit measurement of the measured characteristic through the data port, calculate and display an average correction factor, the average correction factor being the amount of change of the characteristic of the body per each unit of delivered medical agent on average for a predetermined amount of time prior to the current time, receive data defining a correction factor through the data port, receive data defining a duration of time over which the medical agent remains in the body of the patient, calculate a residual bolus value, the residual bolus value defining an estimated amount of any previously-delivered bolus still active in the patient, calculate and display an adjusted bolus amount based on a difference between the desired bolus amount and the residual bolus value prior to executing the deliver command such that a safe amount of medical agent is delivered, and execute the deliver command thereby controlling the pump mechanism to deliver the bolus.

7. The apparatus of claim 6 wherein the data input device is a keypad having one or more buttons.

8. The apparatus of claim 6 wherein the data input device is a data port configured to communicate with a computer.

9. The apparatus of claim 6 wherein the processor is further programmed to control the pump mechanism to simultaneously deliver a basal and the bolus upon executing the deliver command.

13. The apparatus of claim 6 wherein the processor is further configured to receive data defining a desired adjustment level of the characteristic, specified in units of the unit measurement, through the data port, calculate a recommended remedial bolus amount based on the quotient of the desired adjustment level of the characteristic and the correction factor, and calculate the desired bolus amount by setting the desired bolus amount equal to the recommended remedial bolus amount.

14. The apparatus of claim 13 wherein the processor is further configured to adjust the recommended remedial bolus amount.