# US 11,439,754 B1 · Optimizing embedded formulations for drug delivery

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- Number: US 11,439,754 B1
- Document ID: US11439754B1
- Status: Granted
- Kind: B1
- Application number: 17/539,270
- Filed: 2021-12-01
- Granted: 2022-09-13
- Earliest claimed: 2021-12-01
- Assignees: Insulet Corporation
- Applicants: Insulet Corporation
- Inventors: Joon Bok Lee; Yibin Zheng; Jason O'Connor; Ashutosh Zade
- Web page: https://patentgrep.com/patent/US11439754B1

## CPC

- A61M 5/1723: {using feedback of body parameters, e.g. blood sugar or pressure}
- A61M 5/14244: {adapted to be carried by the patient, e.g. portable on the body}
- A61P 3/08: for glucose homeostasis (pancreatic hormones A61P5/48)
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- G16H 20/13: delivered from dispensers
- G16H 20/17: delivered via infusion or injection
- 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
- 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)}
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

Disclosed herein is a method for execution by a drug delivery device for determining an optimal dose of a liquid drug for current cycle of a medication delivery algorithm, the method utilizing a stepwise evaluation of a model and a cost function across a coarse search space consisting of coarse discrete quantities of the drug and a refined search space consisting of refined discrete quantities of the drug.

## Claims

### Claim 1

A method of determining a dose of a drug for a current cycle of a medication delivery algorithm in an automated drug delivery system comprising:
defining a first coarse search space by coarsely delineating a range of possible doses of the drug into coarse discrete quantities;
evaluating a model and a cost function for the current cycle and a predetermined number of future cycles for each coarse discrete quantity in the first coarse search space;
defining a refined search space by delineating, into refined discrete quantities, a range of doses of the drug centered around the coarse discrete quantity having the lowest cost, the refined search space having a finer delineation than the first coarse search space;
evaluating the model and the cost function for the current cycle and the predetermined number of future cycles, wherein the current cycle is evaluated over the refined search space and the predetermined number of future cycles are evaluated over a second coarse search space; and
selecting the refined discrete quantity having the lowest cost as the recommended dose of the drug.

### Claim 2 (depends on 1)

The method of claim 1 wherein the refined discrete quantities are smaller than the coarse discrete quantities.

### Claim 3 (depends on 1)

The method of claim 1 wherein the refined search space is smaller than the first coarse search space.

### Claim 4 (depends on 1)

The method of claim 1 wherein the range of possible doses of the drug ranges from 0 to a maximum quantity determined by the medication delivery algorithm.

### Claim 5 (depends on 4)

The method of claim 4 wherein the maximum quantity is dependent upon safety constraints built into the medication delivery algorithm.

### Claim 6 (depends on 1)

The method of claim 1 wherein the drug is insulin delivered by a wearable drug delivery device.

### Claim 7 (depends on 6)

The method of claim 6 wherein the model is a recursive glucose model used to predict glucose levels of the user in a predetermined number of future cycles based on delivery of a particular quantity of insulin.

### Claim 8 (depends on 7)

The method of claim 7 wherein the cost function calculates the cost for each possible glucose and insulin trajectory and determines the trajectory with a lowest cost.

### Claim 9 (depends on 8)

The method of claim 8 wherein the cost function is based on glucose deviations and insulin delivery deviations, wherein the glucose deviations are calculated against a specific target.

### Claim 10

A system comprising:
a processor;
software implementing a medication delivery algorithm, executed by the processor, the software determining a recommended dose of a drug for a current cycle of the medication delivery algorithm by performing the functions of:
defining a first coarse search space by coarsely delineating a range of possible doses of the drug into coarse discrete quantities;
evaluating a model and a cost function for the current cycle and a predetermined number of future cycles for each coarse discrete quantity in the first coarse search space;
defining a refined search space by delineating, into refined discrete quantities, a range of doses of the drug centered around the coarse discrete quantity having the lowest cost, the refined search space having a finer delineation than the first coarse search space;
evaluating the model and the cost function for the current cycle and the predetermined number of future cycles, wherein the current cycle is evaluated over the refined search space and the predetermined number of future cycles are evaluated over the second coarse search space; and
selecting the refined discrete quantity having the lowest cost as the recommended dose of the drug.

### Claim 11 (depends on 10)

The system of claim 10 further comprising:
a drug delivery device for delivering the recommended dose of the drug to the user.

### Claim 12 (depends on 11)

The system of claim 11 wherein the processor and software are integral with the drug delivery device.

### Claim 13 (depends on 10)

The system of claim 10 wherein the refined discrete quantities are smaller than the coarse discrete quantities.

### Claim 14 (depends on 10)

The system of claim 10 wherein the refined search space is smaller than the first coarse search space.

### Claim 15 (depends on 10)

The system of claim 10 wherein the range of possible doses of the drug ranges from 0 to a maximum quantity determined by the medication delivery algorithm.

### Claim 16 (depends on 15)

The system of claim 15 wherein the maximum quantity is dependent upon safety constraints built into the medication delivery algorithm.

### Claim 17 (depends on 11)

The system of claim 11 wherein the drug is insulin delivered by the wearable drug delivery device.

### Claim 18 (depends on 17)

The system of claim 17 wherein the model is a recursive glucose model used to predict glucose levels of the user in a predetermined number of future cycles based on delivery of a particular quantity of insulin.

### Claim 19 (depends on 18)

The system of claim 18 wherein the cost function calculates the cost for each possible glucose and insulin trajectory and determines the trajectory with a lowest cost.

### Claim 20 (depends on 19)

The system of claim 19 wherein the cost function is based on glucose deviations and insulin delivery deviations, wherein the glucose deviations are calculated against a specific target.
