# US 7,959,598 B2 · Infusion pump systems and methods

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- Number: US 7,959,598 B2
- Document ID: US7959598B2
- Status: Granted
- Kind: B2
- Application number: 12/195,034
- Filed: 2008-08-20
- Published: 2010-02-25
- Granted: 2011-06-14
- Earliest claimed: 2008-08-20
- Assignees: Asante Solutions, Inc.
- Inventors: Mark C. Estes
- Web page: https://patentgrep.com/patent/US7959598B2

## CPC

- A61M 5/1413: {Modular systems comprising interconnecting elements}
- A61M 5/14244: {adapted to be carried by the patient, e.g. portable on the body}
- A61M 5/1456: {with a replaceable reservoir comprising a piston rod to be moved into the reservoir, e.g. the piston rod is part of the removable reservoir}
- A61M 5/1723: {using feedback of body parameters, e.g. blood sugar or pressure}
- G16H 20/17: delivered via infusion or injection
- A61M 5/14248: {of the skin patch type}
- A61M 2005/14208: {with a programmable infusion control system, characterised by the infusion program}
- A61M 2005/14268: {with a reusable and a disposable component}
- A61M 2202/0007: introduced into the body
- A61M 2230/201: Glucose concentration
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

Some embodiments an infusion pump system can be used to determine a user's total insulin load (TIL) that provides an accurate indication of the insulin previously delivered to the user's body which has not yet acted. In particular embodiments, the TIL can account for both the bolus deliveries and the basal deliveries that have occurred over a period of time. Such information may be useful, for example, when the infusion pump is operated in conjunction with a continuous glucose monitoring device.

## Claims

### Claim 1

A medical infusion pump system, comprising:
a portable pump housing that receives insulin for dispensation to a user, the pump housing at least partially containing a pump drive system to dispense the insulin through a flow path to the user;
a controller that activates the pump drive system to dispense the insulin from the portable pump housing;
a monitoring device that communicates glucose information to the controller, the glucose information being indicative of a blood glucose level of the user; and
a user interface coupled to the controller including a display device that contemporaneously displays a glucose value indicative of the blood glucose level of the user and a total insulin load indicative of bolus and basal insulin dosages that have dispensed but not yet acted in the user.

### Claim 2

A medical infusion pump system, comprising:
a portable pump housing that receives insulin for dispensation to a user, the pump housing at least partially containing a pump drive system to dispense the insulin through a flow path to the user;
a controller that activates the pump drive system to dispense the insulin from the portable pump housing;
a monitoring device that communicates glucose information to the controller, the glucose information being indicative of a blood glucose level of the user; and
a user interface coupled to the controller including a display device that contemporaneously displays a glucose value indicative of the blood glucose level of the user and a total insulin load indicative of bolus and basal insulin dosages that have dispensed but not yet acted in the user, and the display device contemporaneously displays the glucose value and the total insulin load in a reference information screen that is displayed when the user has not activated any menu options for a particular period of time.

### Claim 3 (depends on 1)

The system of claim 1, wherein the total insulin load is determined by the controller according to a function that accounts for (i) a bolus insulin load indicative of one or more bolus insulin dosages that have been dispensed into the user but not yet acted in the user, (ii) a basal insulin load indicative of one or more basal insulin dosages that have been dispensed into the user from the portable infusion pump system but not yet acted in the user; and (iii) a previous food component based upon previous food intake that has not yet metabolized in the user.

### Claim 4 (depends on 1)

The system of claim 1, further comprising a computer-readable memory device coupled to the controller that stores one or more calculated values for the total insulin load and one or more corresponding time values.

### Claim 5 (depends on 4)

The system of claim 4, wherein the controller further comprises a data connection instrument to export the calculated values for the total insulin load and the corresponding time values to an external computer system.

### Claim 6 (depends on 5)

The system of claim 5, wherein when the controller exports the calculated values for the total insulin load and the corresponding time values to the external computer system, the external computer system displays the calculated values for the total insulin load in a time-based plot.

### Claim 7 (depends on 1)

The system of claim 1, wherein the user interface includes the display device and a plurality of user-actuatable buttons.

### Claim 8 (depends on 7)

The system of claim 7, the display device contemporaneously displays the glucose value and the total insulin load in a default screen that is displayed when the user has not actuated any of the buttons for a particular period of time.

### Claim 9 (depends on 8)

The system of claim 8, wherein the total insulin load is determined by the controller according to a function that accounts for at least (i) a bolus insulin load indicative of one or more bolus insulin dosages that have been dispensed into the user but not yet acted in the user, and (ii) a basal insulin load indicative of one or more basal insulin dosages that have been dispensed into the user from the portable infusion pump system but not yet acted in the user.

### Claim 10 (depends on 1)

The system of claim 1, wherein the controller comprises a controller housing that removably attaches to the pump housing, the controller being electrically connected to the pump drive system when the controller housing is removably attached to the pump housing.

### Claim 11 (depends on 10)

The system of claim 10, wherein the controller is a reusable device and the pump housing and pump drive system are disposable and nonreusable.

### Claim 12 (depends on 1)

The system of claim 1, wherein the portable pump housing receives a prefilled cartridge of the insulin through an opening in the pump housing that is coverable with a cap device, and the flow path of the insulin comprises and an infusion set tube that extends from the cap device to the user.

### Claim 13

A medical infusion pump system, comprising:
a portable pump housing that receives insulin for dispensation to a user, the pump housing at least partially containing a pump drive system to dispense the insulin through a flow path to the user;
a controller that activates the pump drive system to dispense the insulin from the portable pump housing;
a monitoring device that communicates glucose information to the controller, the glucose information being indicative of a blood glucose level of the user, wherein the monitoring device comprises a portable housing wearable on the user's skin, a sensor shaft that penetrates into the user's skin, and a wireless communication device to transmit the glucose information to a wireless communication device of the controller; and
a user interface coupled to the controller including a display device that contemporaneously displays a glucose value indicative of the blood glucose level of the user and a total insulin load indicative of bolus and basal insulin dosages that have dispensed but not yet acted in the user.

### Claim 14 (depends on 1)

A method of operating the medical infusion pump system of claim 1, comprising:
determining the total insulin load for a particular time that accounts for a bolus insulin load, a basal insulin load, and a previous food component, wherein: the bolus insulin load is indicative of one or more bolus insulin dosages that have been dispensed into a user from the medical infusion pump system but not yet acted in the user, the basal insulin load is indicative of one or more basal insulin dosages that have been dispensed into the user from the medical infusion pump system but not yet acted in the user; and the previous food component is based upon previous food intake that has not yet metabolized in the user;
storing a calculated value for the total insulin load and a time value for the particular time in a computer-readable memory device of the medical infusion pump system; and
displaying the calculated value for the total insulin load on the display device of the medical infusion pump system.

### Claim 15 (depends on 14)

The method of claim 14, wherein displaying the calculated value for the total insulin load on the display device comprises contemporaneously displaying the glucose value indicative of the blood glucose level of the user and the calculated value for the total insulin load.

### Claim 16 (depends on 14)

The method of claim 14, further comprising providing plot data to at least partially define a time-based plot of calculated values for total insulin load versus time.

### Claim 17 (depends on 16)

The method of claim 16, further comprising displaying the time-based plot of calculated values for total insulin load versus time on the display device of the medical infusion pump system.

### Claim 18 (depends on 16)

The method of claim 16, wherein the plot data is exported to an external computer system to display the time-based plot of calculated values for total insulin load versus time on a display device of the external computer system.

### Claim 19 (depends on 14)

The method of claim 14, further comprising receiving glucose information from the monitoring device of the medical infusion pump system, the glucose information being indicative of a detected blood glucose level of the user.

### Claim 20 (depends on 19)

The method of claim 19, further comprising displaying the glucose value indicative of the detected blood glucose level of the user on the display device of the portable infusion pump system, wherein the display device contemporaneously displays the glucose value and the calculated value for the total insulin load.

### Claim 21 (depends on 1)

A method of operating the medical infusion pump system of claim 1, comprising:
receiving user input indicative of a request to suggest a bolus dosage;
receiving user input indicative of a proposed food intake to be consumed by a user of the medical infusion pump system;
receiving glucose information indicative of a glucose level of the user;
determining a bolus suggestion value according to a function that includes the total insulin load of the user, wherein the total insulin load accounts for (i) a bolus insulin load indicative of one or more bolus insulin dosages that have been dispensed into the user but not yet acted in the user, (ii) a basal insulin load indicative of one or more basal insulin dosages that have been dispensed into the user from the medical infusion pump system but not yet acted in the user; and (iii) a previous food component based upon previous food intake that has not yet metabolized in the user; and
displaying the bolus suggestion value on the display device of the medical infusion pump system.

### Claim 22 (depends on 21)

The method of claim 21, wherein further comprising prompting the user initiate a bolus dosage in the amount of the suggested bolus value displayed on the display device.

### Claim 23 (depends on 21)

The method of claim 21, wherein the bolus suggestion value is determined according to the function:
bolus
⁢
⁢
suggestion
⁢
⁢
value
=
(
proposed
⁢
⁢
food
⁢
⁢
intake
⁢
⁢
bolus
)
+
(
correction
⁢
⁢
bolus
)
-
(
total
⁢
⁢
insulin
⁢
⁢
load
⁢
⁢
of
⁢
⁢
the
⁢
⁢
user
)
.

### Claim 24 (depends on 23)

The method of claim 23, wherein the proposed food intake bolus is determine according to: (estimated value of carbohydrates to be consumed)×(carbohydrate ratio).

### Claim 25 (depends on 23)

The method of claim 23, wherein the correction bolus is determine according to: (the glucose level of the user−a target glucose level)×(an insulin sensitivity factor).

### Claim 26 (depends on 23)

The method of claim 23, wherein the total insulin load of the user at time tn is determine according to: (bolus insulin load at time tn)+(basal insulin load at time tn)−(previous food component at time tn).

### Claim 27 (depends on 2)

The system of claim 2, wherein the total insulin load is determined by the controller according to a function that accounts for (i) a bolus insulin load indicative of one or more bolus insulin dosages that have been dispensed into the user but not yet acted in the user, (ii) a basal insulin load indicative of one or more basal insulin dosages that have been dispensed into the user from the portable infusion pump system but not yet acted in the user; and (iii) a previous food component based upon previous food intake that has not yet metabolized in the user.

### Claim 28 (depends on 2)

The system of claim 2, further comprising a computer-readable memory device coupled to the controller that stores one or more calculated values for the total insulin load and one or more corresponding time values.

### Claim 29 (depends on 2)

The system of claim 2, wherein the controller comprises a controller housing that removably attaches to the pump housing, the controller being electrically connected to the pump drive system when the controller housing is removably attached to the pump housing.

### Claim 30 (depends on 2)

The system of claim 2, wherein the portable pump housing receives a prefilled cartridge of the insulin through an opening in the pump housing that is coverable with a cap device, and the flow path of the insulin comprises and an infusion set tube that extends from the cap device to the user.

### Claim 31 (depends on 2)

The system of claim 2, wherein the monitoring device comprises a portable housing wearable on the user's skin, a sensor shaft that penetrates into the user's skin, and a wireless communication device to transmit the glucose information to a wireless communication device of the controller.

### Claim 32 (depends on 13)

The system of claim 13, wherein the total insulin load is determined by the controller according to a function that accounts for (i) a bolus insulin load indicative of one or more bolus insulin dosages that have been dispensed into the user but not yet acted in the user, (ii) a basal insulin load indicative of one or more basal insulin dosages that have been dispensed into the user from the portable infusion pump system but not yet acted in the user; and (iii) a previous food component based upon previous food intake that has not yet metabolized in the user.

### Claim 33 (depends on 13)

The system of claim 13, further comprising a computer-readable memory device coupled to the controller that stores one or more calculated values for the total insulin load and one or more corresponding time values.

### Claim 34 (depends on 13)

The system of claim 13, wherein the controller comprises a controller housing that removably attaches to the pump housing, the controller being electrically connected to the pump drive system when the controller housing is removably attached to the pump housing.

### Claim 35 (depends on 13)

The system of claim 13, wherein the portable pump housing receives a prefilled cartridge of the insulin through an opening in the pump housing that is coverable with a cap device, and the flow path of the insulin comprises and an infusion set tube that extends from the cap device to the user.
