IP Library Granted Patent US 11,464,908
Granted Patent B2
US 11,464,908 · App. 16/793,662 · Granted Oct 11, 2022

Methods and apparatus for monitoring infusion sites for ambulatory infusion pumps

Inventors: Michael Michaud (San Diego, CA); Geoffrey A. Kruse (San Diego, CA)
Assignee: Tandem Diabetes Care, Inc.
A61M5/1723A61M5/14248A61M2205/18A61M2205/505A61M2205/52A61M2230/201
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Quick Facts
Patent No.
US 11,464,908
App. No.
16/793,662
Granted
Oct 11, 2022
Kind
B2
Abstract

Disclosed herein are apparatuses and methods for improved use of infusion sites for infusion pumps. Apparatuses and methods for delivery of medicaments such as insulin disclosed herein can increase the effectiveness of therapy by more accurately determining when an infusion site is no longer absorbing insulin at an acceptable rate as well as determining the effectiveness of different infusion sites on the body with respect to each other and over time.

Claims (31)

1. A method of providing diabetes therapy to a patient with a portable infusion pump, comprising:

detecting that a patient has inserted a cannula for delivery of medicament with the portable infusion pump at an infusion site on a body of the patient;

delivering the medicament to the patient at the infusion site with the portable infusion pump;

receiving data obtained by a glucose sensor;

monitoring glucose levels of the patient based on the data obtained by the glucose sensor;

determining, based on a stored correction factor of the patient, if the monitored glucose levels are lowering as expected in response to the medicament being delivered to the patient; and

providing an infusion site alert to the patient if it is determined that the monitored glucose levels are not lowering as expected in response to the medicament.

2. The method of claim 1 , wherein providing an infusion site alert includes instructing the patient to rotate to a new infusion site at a different location on the body.

3. The method of claim 2 , further comprising not instructing the user to rotate to a new infusion site until it is determined that the monitored glucose levels are not lowering as expected in response to the medicament.

4. The method of claim 1 , wherein detecting that the patient has inserted the cannula at the infusion site includes receiving user input instructing the portable infusion pump to fill the cannula with the medicament.

5. The method of claim 1 , wherein detecting that the patient has inserted the cannula at the infusion site includes receiving user input instructing the portable infusion pump to fill tubing extending between the portable infusion pump and the cannula with the medicament.

6. The method of claim 1 , wherein determining if the monitored glucose levels are lowering as expected in response to the medicament being delivered to the patient includes determining if the monitored glucose levels are lowering as expected in response to one or more of preprogrammed basal insulin delivery, meal boluses and correction boluses.

7. The method of claim 1 , wherein determining if the monitored glucose levels are lowering as expected in response to the medicament being delivered to the patient includes determining if the monitored glucose levels are lowering as expected in response to a test bolus of insulin delivered to determine a response at the infusion site rather than in response to actual or anticipated increases in glucose levels.

8. The method of claim 1 , wherein determining if the monitored glucose levels are lowering as expected in response to the medicament being delivered to the patient includes continuously monitoring glucose levels with respect to the medicament being delivered.

9. The method of claim 1 , wherein determining if the monitored glucose levels are lowering as expected in response to the medicament being delivered to the patient includes periodically monitoring glucose levels with respect to the medicament being delivered at regular intervals.

10. The method of claim 1 , further comprising reviewing other factors that could cause the monitored glucose levels to not lower as expected in response to the medicament being delivered to the patient prior to providing the infusion site alert.

11. The method of claim 10 , wherein reviewing other factors includes determining if a meal has recently been consumed by the patient.

12. The method of claim 10 , wherein reviewing other factors includes determining if the patient is exercising.

13. The method of claim 1 , wherein determining if the monitored glucose levels are lowering as expected in response to the medicament being delivered to the patient based on a stored correction factor of the patient includes calculating an effective correction factor for the patient based on the monitored glucose levels and delivered medicament and comparing the effective correction factor to the stored correction factor.

14. The method of claim 1 , determining if the monitored glucose levels are lowering as expected in response to the medicament being delivered to the patient based on a stored correction factor of the patient includes determining if an amount of insulin delivered over a predetermined period of time lowered the user's glucose level as expected in view of the stored correction factor.

15. A method of providing diabetes therapy to a patient with a portable infusion pump, comprising:

detecting that a patient has inserted a cannula for delivery of medicament with the portable infusion pump at an infusion site on a body of the patient;

delivering the medicament to the patient at the infusion site with the portable infusion pump;

receiving data obtained by a glucose sensor;

monitoring glucose levels of the patient based on the data obtained by the glucose sensor;

determining if the monitored glucose levels are lowering as expected in response to the medicament being delivered to the patient including determining if an amount of insulin delivered over a predetermined period of time lowered the user's glucose level as expected in view of a predetermined correction factor for the patient; and

providing an infusion site alert to the patient if it is determined that the monitored glucose levels are not lowering as expected in response to the medicament.

16. The method of claim 15 , wherein determining if an amount of insulin delivered over a predetermined period of time lowered the user's glucose level as expected in view of the stored correction factor includes calculating an effective correction factor for the patient based on the amount of insulin and amount that the user's glucose level lowered and comparing the effective correction factor to the stored correction factor.

17. The method of claim 15 , further comprising reviewing other factors that could cause the monitored glucose levels to not lower as expected in response to the medicament being delivered to the patient prior to providing the infusion site alert.

18. The method of claim 17 , wherein reviewing other factors includes determining if a meal has recently been consumed by the patient.

19. The method of claim 17 , wherein reviewing other factors includes determining if the patient is exercising.

Assignments (3)
RELEASE OF SECURITY INTEREST Recorded Mar 24, 2024
From: BANK OF AMERICA, N.A., AS ADMINISTRATIVE AGENT
To: TANDEM DIABETES CARE, INC.
Reel/Frame 066880/0918 →
SECURITY INTEREST Recorded May 25, 2022
From: TANDEM DIABETES CARE, INC.
To: BANK OF AMERICA, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 060179/0100 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 19, 2020
From: MICHAUD, MICHAEL; KRUSE, GEOFFREY A.
To: TANDEM DIABETES CARE, INC.
Reel/Frame 052164/0621 →
Cited By (5)
US 12,383,673 US 12,431,104 US 12,567,493 US 12,667,666 US 12,688,936