IP Library Granted Patent US 12,465,686
Granted Patent B2
US 12,465,686 · App. 17/882,469 · Granted Nov 11, 2025

Emergency medicament dose control

Inventors: Michael J. Rosinko (Las Vegas, NV); Firas H. El-Khatib (Allston, MA); Edward R. Damiano (Acton, MA); David Chi-Wai Lim (Irvine, CA); Edward B. Raskin (Irvine, CA)
Assignee: Beta Bionics, Inc.
A61M5/1723A61B5/14532G16H20/17
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Quick Facts
Patent No.
US 12,465,686
App. No.
17/882,469
Granted
Nov 11, 2025
Kind
B2
Abstract

Automated glucose level control system that provide therapy to a subject, such as glucose control, are disclosed. The system generates dose control signals using control algorithms configured to autonomously determine doses of insulin to be infused into a subject. When the system determines that an initial dose control signal does not indicate health-appropriate therapy, the system can modify a manual therapy instruction and transmit an emergency dose control signal to the medicament pump. Disclosed systems and devices can track insulin therapy administered to the subject over a tracking period, including storing an indication of the autonomously determined doses of insulin delivered to the subject. The system can generate a backup therapy protocol with insulin therapy instructions based at least in part on the insulin therapy administered to the subject over the tracking period.

Claims (29)

1 . A glucose level control system configured to modify a manual therapy instruction and to generate an emergency dose control signal for commanding administration of modified glucose control therapy to a subject via a medicament pump, the glucose level control system comprising:

a data interface configured to receive a glucose level of the subject;

a non-transitory memory configured to store specific computer-executable instructions; and

an electronic processor in communication with the non-transitory memory and configured to execute the specific computer-executable instructions to at least:

receive, via a manual therapy control interface, the manual therapy instruction;

based on the manual therapy instruction, transmit an initial dose control signal to a pump controller of the medicament pump;

receive, via the data interface, the glucose level of the subject; determine, based at least in part on the glucose level, that the initial dose

control signal does not indicate health-appropriate therapy;

based on the determination that the initial dose control signal does not indicate health-appropriate therapy, generate the emergency dose control signal for commanding administration of modified glucose control therapy to the subject via the medicament pump; and

based on the emergency dose control signal, modify the manual therapy instruction and transmit, via the data interface, the emergency dose control signal to the pump controller of the medicament pump along with graphic user interface updating and concomitant visual displays.

2 . The glucose level control system of claim 1 , wherein the specific computer-executable instructions, when executed by the electronic processor, are configured to:

receive, via the manual therapy control interface, one or more of a rate of insulin delivered to the subject, and/or a rate of glucagon delivered to the subject.

3 . The glucose level control system of claim 1 , wherein the specific computer-executable instructions, when executed by the electronic processor, are configured to:

receive, via the manual therapy control interface, a rate of nutrition delivered to the subject.

4 . The glucose level control system of claim 1 , wherein the specific computer-executable instructions, when executed by the electronic processor, are configured to:

receive the glucose level of the subject from a glucose sensor.

5 . The glucose level control system of claim 4 , wherein the specific computer-executable instructions, when executed by the electronic processor, are configured to:

receive the glucose level of the subject from the glucose sensor at a regular interval over a time period.

6 . The glucose level control system of claim 5 , wherein the time period is at least an hour.

7 . The glucose level control system of claim 5 , wherein determining that the initial

dose control signal does not indicate health-appropriate therapy comprises determining a time-varying glucose level of the subject over the time period.

8 . The glucose level control system of claim 1 , wherein determining that the initial dose control signal does not indicate health-appropriate therapy comprises estimating one or more of a rate of insulin delivered to the subject, and/or a rate of glucagon delivered to the subject.

9 . The glucose level control system of claim 8 , wherein estimating the amount of insulin in the subject comprises determining an amount of insulin delivered to the subject.

10 . The glucose level control system of claim 8 , wherein estimating the amount of insulin in the subject comprises determining a rate of insulin absorption in the subject.

11 . The glucose level control system of claim 1 , wherein determining that the initial dose control signal does not indicate health-appropriate therapy comprises receiving a weight of the subject.

12 . The glucose level control system of claim 1 , wherein the initial dose control signal is configured to command delivery of insulin to the subject at a first rate, and wherein the emergency dose control signal is configured to command delivery of insulin at a second rate lower than the first rate.

13 . The glucose level control system of claim 1 , wherein the initial dose control signal is configured to command delivery of glucagon to the subject at a first rate, and wherein the emergency dose control signal is configured to command delivery of glucagon at a second rate higher than the first rate.

14 . The glucose level control system of claim 1 , wherein determining that the initial dose control signal does not indicate health-appropriate therapy is based on the manual therapy instruction.

15 . The glucose level control system of claim 1 , wherein modifying the manual therapy instruction comprises temporarily overriding the manual therapy instruction.

Continuity (25)
Continuation PCTUS2022071308 · Mar 24, 2022
Continuation In Part PCTUS2022017368 · Feb 22, 2022
Continuation In Part PCTUS2021064228 · Dec 17, 2021
Continuation In Part PCTUS2021072742 · Dec 3, 2021
Continuation In Part 17212984 · Mar 25, 2021
Provisional Application 63321514 · Mar 18, 2022
Provisional Application 63320591 · Mar 16, 2022
Provisional Application 63320587 · Mar 16, 2022
Provisional Application 63295361 · Dec 30, 2021
Provisional Application 63264645 · Nov 29, 2021
Provisional Application 63263602 · Nov 5, 2021
Provisional Application 63276481 · Nov 5, 2021
Provisional Application 63249975 · Sep 29, 2021
Provisional Application 63261290 · Sep 16, 2021
Provisional Application 63239365 · Aug 31, 2021
Provisional Application 63238670 · Aug 30, 2021
Provisional Application 63216177 · Jun 29, 2021
Provisional Application 63215857 · Jun 28, 2021
Provisional Application 63212521 · Jun 18, 2021
Provisional Application 63194126 · May 27, 2021
Provisional Application 63183900 · May 4, 2021
Provisional Application 63169112 · Mar 31, 2021
Provisional Application 63168203 · Mar 30, 2021
Provisional Application 63167563 · Mar 29, 2021
Related Publication 20230166035A1 · Jun 1, 2023
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