# US 2021/0241876 A1 · Insulin and pramlintide delivery systems, methods, and devices

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 2021/0241876 A1
- Document ID: US20210241876A1
- Status: Published application
- Kind: A1
- Application number: 16/973,498
- Filed: 2019-06-20
- Published: 2021-08-05
- Earliest claimed: 2018-06-22
- Assignees: Eli Lilly and Company
- Applicants: Eli Lilly and Company
- Inventors: Ahmad Mohamad HAIDAR
- Web page: https://patentgrep.com/patent/US20210241876A1

## CPC

- G16H 20/17: delivered via infusion or injection
- G16H 40/63: for local operation
- A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement}
- A61B 5/4839: {combined with drug delivery}
- A61K 38/28: Insulins
- A61M 5/142: Pressure infusion, e.g. using pumps
- A61M 5/1723: {using feedback of body parameters, e.g. blood sugar or pressure}
- G16H 40/60: for the operation of medical equipment or devices
- G16H 50/20: for computer-aided diagnosis, e.g. based on medical expert systems
- A61M 2005/14208: {with a programmable infusion control system, characterised by the infusion program}
- A61M 2230/201: Glucose concentration
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- 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)}

## Abstract

The present disclosure relates to systems and methods for controlling physiological glucose concentrations in a patient.

## Claims

### Claim 1

A system to control glucose in a patient, the system comprising:
a medication delivery device configured to deliver medication to the patient; and
a controller in communication with the medication delivery device and including control logic operative to calculate a bolus delivery schedule comprising an initial bolus delivery amount and a delayed bolus delivery amount, wherein the initial bolus delivery amount relative to the delayed bolus delivery amount is based, at least in part, on a pre-meal glucose level.

### Claim 2 (depends on 1)

The system of claim 1, wherein the initial bolus delivery amount and the delayed bolus delivery amount are based, at least in part, on comparing a pre-meal glucose level to an upper threshold and a lower threshold.

### Claim 3 (depends on 2)

The system of claim 2, wherein the initial bolus delivery amount is greater than the delayed bolus delivery amount when the pre-meal glucose level is greater than the upper threshold.

### Claim 4 (depends on 2)

The system of claim 2, wherein the delayed bolus delivery amount is half the initial bolus delivery amount.

### Claim 5 (depends on 4)

The system of claim 4, wherein the initial bolus delivery amount is equal to the delayed bolus delivery amount when the pre-meal glucose level is between than the lower threshold and the upper threshold.

### Claim 6 (depends on 2)

The system of claim 2, wherein the initial bolus delivery amount is less than the delayed bolus delivery amount when the pre-meal glucose level is less than the lower threshold.

### Claim 7 (depends on 2)

The system of claim 2, wherein the upper threshold is 8 mmol/L and the lower threshold is 6 mmol/L.

### Claim 8 (depends on 1)

The system of claim 1, wherein the initial bolus delivery amount is delivered in a first delivery and the delayed bolus delivery amount is delivered in a second delivery and a third delivery.

### Claim 9 (depends on 8)

The system of claim 8, wherein the first, second, and third deliveries are scheduled 5-15 minutes apart from each other.

### Claim 10 (depends on 1)

The system of claim 1, wherein the initial bolus delivery amount and the delayed bolus delivery amount comprise insulin and pramlintide.

### Claim 11 (depends on 10)

The system of claim 10, wherein the insulin and the pramlintide are delivered as a co-formulation.

### Claim 12 (depends on 10)

The system of claim 10, wherein the insulin and the pramlintide are delivered separately.

### Claim 13 (depends on 10)

The system of claim 10, wherein the insulin and the pramlintide are delivered at a fixed ratio.

### Claim 14 (depends on 10)

The system of claim 10, wherein the fixed ratio is 6 μg/u.

### Claim 15 (depends on 1)

The system of claim 1, wherein the medication delivery device comprises a single reservoir for storing medication.

### Claim 16 (depends on 1)

The system of claim 1, wherein the medication delivery device comprises 2 or 3 reservoirs for storing medication.

### Claim 17 (depends on 16)

The system of claim 16, wherein the medication delivery device includes a single injector.

### Claim 18 (depends on 16)

The system of claim 16, wherein the medication delivery device includes multiple injectors.

### Claim 19 (depends on 1)

The system of claim 1, wherein the medication delivery device includes a single pump.

### Claim 20 (depends on 1)

The system of claim 1, wherein the medication delivery device includes multiple pumps.

### Claim 21 (depends on 1)

The system of claim 1, wherein the initial bolus delivery amount is 75% of a total calculated bolus and the delayed bolus delivery amount is 25% of the total calculated bolus.

### Claim 22 (depends on 1)

The system of claim 1, wherein the initial bolus delivery amount is 25-50% of a total calculated bolus and the delayed bolus delivery amount is 50-75% of the total calculated bolus.

### Claim 23 (depends on 22)

The system of claim 22, wherein the delayed bolus delivery amount is allocated based on a function of a current or estimated glucose level.

### Claim 24 (depends on 1)

The system of claim 1, wherein the delayed bolus delivery amount is allocated between two bolus deliveries that are substantially equal to each other.

### Claim 25 (depends on 1)

The system of claim 1, wherein the initial bolus delivery amount and the delayed bolus delivery amount are based, at least in part, on a carbohydrate content of a meal.

### Claim 26 (depends on 25)

The system of claim 25, wherein the delayed bolus delivery amount is decreased if a carbohydrate content of a meal is less than a predetermined threshold.

### Claim 27 (depends on 26)

The system of claim 26, wherein the predetermined threshold is 30-50 grams.

### Claim 28 (depends on 1)

The system of claim 1, wherein the medication delivery device is configured to deliver insulin to the patient, in response to the calculated bolus delivery schedule.

### Claim 29 (depends on 1)

The system of claim 1, further comprising:
a user interface in communication with the controller and configured to receive input from the patient.

### Claim 30 (depends on 1)

The system of claim 1, further comprising:
a glucose measurement device in communication with the controller and configured to measure glucose data associated with the patient.

### Claim 31

A system to control glucose in a patient, the system comprising:
a medication delivery device configured to deliver medication to the patient; and
means for calculating a bolus delivery schedule comprising an initial bolus delivery amount and a delayed bolus delivery amount based, at least in part, on a pre-meal glucose level.

### Claim 32 (depends on 31)

The system of claim 31, wherein the initial bolus delivery amount relative to the delayed bolus delivery amount is based, at least in part, on a pre-meal glucose level.

### Claim at position 33

33-70. (canceled)