# US 11,027,073 B2 · Therapy assist information and/or tracking device and related methods and systems

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- Number: US 11,027,073 B2
- Document ID: US11027073B2
- Status: Granted
- Kind: B2
- Application number: 16/218,026
- Filed: 2018-12-12
- Published: 2019-06-20
- Granted: 2021-06-08
- Earliest claimed: 2017-12-12
- Assignees: Bigfoot Biomedical, Inc.
- Applicants: Bigfoot Biomedical, Inc.
- Inventors: John Sjolund; Ambika Srinath; Andrew Bochenko; George Crothall; Bryan Mazlish; Lane Desborough; Jennifer Martin Block; Sarah Matarese; Linda Mackowiak
- Web page: https://patentgrep.com/patent/US11027073B2

## CPC

- A61M 5/31546: {Electrically operated dose setting, e.g. input via touch screen or plus/minus buttons}
- A61B 5/0004: {characterised by the type of physiological signal transmitted}
- A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement}
- A61B 5/4836: {Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence)}
- A61B 5/4839: {combined with drug delivery}
- A61B 5/7405: {using sound}
- A61B 5/7435: {Displaying user selection data, e.g. icons in a graphical user interface}
- A61B 5/7455: {characterised by tactile indication, e.g. vibration or electrical stimulation}
- A61B 5/746: {Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms}
- A61K 38/28: Insulins
- A61M 5/003: {Kits for diabetics}
- A61M 5/009: {Electronic or electro-mechanical add-on modules}
- A61M 5/168: Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters
- A61M 5/20: Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically (A61M5/142 takes precedence)
- A61M 5/31525: {Dosing (burettes, pipettes B01L3/02)}
- A61M 5/3202: {Devices for protection of the needle before use, e.g. caps (A61M5/50 takes precedence; protectors for sharps A61B50/3001)}
- G16H 20/13: delivered from dispensers
- G16H 20/17: delivered via infusion or injection
- G16H 20/60: relating to nutrition control, e.g. diets
- G16H 40/63: for local operation
- G16H 40/67: for remote operation
- G16H 50/20: for computer-aided diagnosis, e.g. based on medical expert systems
- G16H 50/30: for calculating health indices; for individual health risk assessment
- A61B 5/14546: {for measuring analytes not otherwise provided for, e.g. ions, cytochromes}
- A61B 5/681: {Wristwatch-type devices}
- A61M 5/24: Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or cartridges, e.g. automatic
- A61M 2005/14208: {with a programmable infusion control system, characterised by the infusion program}
- A61M 2005/2006: {Having specific accessories}
- A61M 2005/3125: {Display means, e.g. to indicate dose setting}
- A61M 2205/18: with alarm
- A61M 2205/3306: Optical measuring means
- A61M 2205/3561: local, e.g. within room or hospital
- A61M 2205/3584: using modem, internet or Bluetooth®
- A61M 2205/502: User interfaces, e.g. screens or keyboards
- A61M 2205/505: Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
- A61M 2205/581: by audible feedback
- A61M 2205/582: by tactile feedback
- A61M 2205/583: by visual feedback
- A61M 2209/06: Packaging for specific medical equipment
- 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)}
- 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)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

A monitoring feature, such as, for example, a pen cap, for an insulin delivery device may include at least one circuit adapted to detect at least one of a capping or decapping of the pen cap from an insulin pen and a processor for using information to the at least one of a capping or decapping of the pen cap. A monitoring feature for an insulin delivery device includes at least one circuit adapted to detect use of the insulin delivery device.

## Claims

### Claim 1

A pen cap for an insulin pen comprising:
at least one input device adapted to receive glucose data;
at least one circuit adapted to detect at least one of a capping or decapping of the pen cap from an insulin pen;
at least one user interface to communicate at least one of therapy relevant information, therapy recommendations, or a time of the at least one of a capping or decapping of the pen cap;
memory to store at least one user-specific dosage parameter or recommended dose; and
at least one processor adapted to determine content presented by the user interface, the processor using information relating to the at least one of a capping or decapping of the pen cap,
wherein the pen cap is adapted to be responsive to the pen cap being capped on the insulin pen for at least a threshold period of time, and to display a recommended correction dose of insulin based on an insulin sensitivity factor and a target glucose value stored in memory.

### Claim 2 (depends on 1)

The pen cap of claim 1, wherein the pen cap is configured to be utilized with one of a long-acting insulin pen or a rapid-acting insulin pen.

### Claim 3 (depends on 1)

The pen cap of claim 1, wherein the pen cap is configure to generate, with the at least one input device, at least a first wireless signal and a second wireless signal, wherein the second wireless signal has a range that is greater than range of the first wireless signal.

### Claim 4 (depends on 3)

The pen cap of claim 3, wherein the first wireless signal is configured to communicate with a glucose monitor when the pen cap is positioned in proximity to the glucose monitor.

### Claim 5 (depends on 4)

The pen cap of claim 4, wherein the second wireless signal is configured to communicate with at least one of the glucose monitor or another remote device.

### Claim 6 (depends on 4)

The pen cap of claim 4, wherein the second wireless signal is configured to automatically communicate with at least one of the glucose monitor or another remote device.

### Claim 7 (depends on 4)

The pen cap of claim 4, wherein the at least one input device comprises at least one wireless radio.

### Claim 8 (depends on 1)

The pen cap of claim 1, wherein the at least one input device comprises a wireless communication interface is configured to communicate with a glucose sensor system via a near field communication protocol when the pen cap is positioned in proximity to at least one part of the glucose sensor system.

### Claim 9 (depends on 8)

The pen cap of claim 8, wherein the wireless communication interface is adapted to communicate with the glucose sensor system using a first wireless communication technique having a first communication range and the wireless communication interface is adapted to communicate with a mobile computing device using a second wireless communication technique having a second communication range, the second communication range being greater than the first communication range.

### Claim 10 (depends on 1)

The pen cap of claim 1, wherein the pen cap is configured to communicate with a glucose sensor system comprising a flash glucose monitor.

### Claim 11 (depends on 1)

The pen cap of claim 1, wherein the content includes a representation of a percentage of active insulin remaining within a user based on a time of a previous capping or decapping of the pen cap and a current time.

### Claim 12 (depends on 11)

The pen cap of claim 11, wherein the pen cap is adapted to determine an amount of insulin remaining in the insulin pen and to determine a dose amount for the time of a previous capping or decapping, wherein the pen cap displays an estimation of active insulin remaining within the user based a current time and the times and dose amounts associated with one or more a previous capping or decapping of the pen cap.

### Claim 13

A pen cap for an insulin delivery device comprising:
at least one input device adapted to receive glucose data;
at least one circuit adapted to detect movement of the pen cap;
memory to store at least one user-specific dosage parameter or recommended dose; and
at least one processor adapted to determine content presented by a user interface, the processor using information relating to the use of the insulin delivery device,
wherein the pen cap is adapted to be responsive to the pen cap being motionless for at least a threshold period of time, and to display a recommended correction dose of insulin based on an insulin sensitivity factor and a target glucose value stored in memory.