# US 11,896,797 B2 · Pen cap for insulin injection pens and associated methods and systems

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- Number: US 11,896,797 B2
- Document ID: US11896797B2
- Status: Granted
- Kind: B2
- Application number: 17/249,887
- Filed: 2021-03-17
- Published: 2021-07-08
- Granted: 2024-02-13
- Earliest claimed: 2017-12-12
- Assignees: Bigfoot Biomedical, Inc.
- Applicants: Bigfoot Biomedical, Inc.
- Inventors: John Sjolund; Ambika Srinath; Andrew Bochenko; George Crothall; Bryan Mazlish; Jennifer Martin Block; Sarah Matarese; Linda Mackowiak; Lane Desborough
- Web page: https://patentgrep.com/patent/US11896797B2

## CPC

- A61M 5/003: {Kits for diabetics}
- A61B 5/0004: {characterised by the type of physiological signal transmitted}
- A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement}
- A61B 5/4839: {combined with drug delivery}
- A61B 5/7405: {using sound}
- A61B 5/743: {Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots}
- 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}
- A61M 5/3202: {Devices for protection of the needle before use, e.g. caps (A61M5/50 takes precedence; protectors for sharps A61B50/3001)}
- A61M 2005/2006: {Having specific accessories}
- A61M 2205/18: with alarm
- A61M 2205/3306: Optical measuring means
- A61M 2205/3584: using modem, internet or Bluetooth®
- A61M 2205/505: Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
- A61M 2205/6063: Optical identification systems
- 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)

## Abstract

One or more embodiments of the disclosure relate, generally, to a pen cap for a manual insulin delivery device. Such a pen cap may include a wireless communication interface, a detection circuit, a user interface, and a processor and memory. The detection circuit may be configured to detect cappings and decappings of the pen cap from a manual insulin delivery device. Timing information and recommendations related to capping and decapping of the pen cap may be presented to a user.

## Claims

### Claim 1

A pen cap for a manual insulin delivery device, comprising:
at least one processor; and
at least one non-transitory computer-readable storage medium storing instructions thereon that, when executed by the at least one processor, cause the at least one processor to:
determine that the pen cap has been capped on the manual insulin delivery device for at least a first threshold period of time; and
cause an at least one user interface of the pen cap to display a recommended correction dose of insulin responsive to the determination that the pen cap has been capped on the manual insulin delivery device for at least the first threshold period of time.

### Claim 2 (depends on 1)

The pen cap of claim 1, further comprising instructions that, when executed by the at least one processor, cause the at least one processor to:
responsive to the pen cap being recapped subsequent to a period of being decapped, determining that the pen cap has been decapped for less than a second threshold period of time; and
responsive to the determination that the pen cap has been decapped for less than a second threshold period of time, determine that the pen cap qualifies as being identified as capped during the period of being decapped in regard to a determination to display the recommended correction dose of insulin.

### Claim 3 (depends on 1)

The pen cap of claim 1, wherein the recommended correction dose of insulin is based at least partially on an insulin sensitivity factor and target glucose value associated with a user.

### Claim 4 (depends on 1)

The pen cap of claim 1, further comprising instructions that, when executed by the at least one processor, cause the pen cap detect one or more cappings and one or more decappings of the pen cap from the manual insulin delivery device via at least one detection circuit.

### Claim 5 (depends on 1)

The pen cap of claim 1, further comprising instructions that, when executed by the at least one processor, cause the pen cap to present one or more of therapy relevant information, therapy recommendations, and timing information associated with detected cappings or detected decappings of the pen cap via the at least one user interface.

### Claim 6 (depends on 1)

The pen cap of claim 1, further comprising instructions that, when executed by the at least one processor, cause the pen cap to receive measurement data from a glucose sensor system and via a wireless communication interface.

### Claim 7 (depends on 6)

The pen cap of claim 6, further comprising instructions that, when executed by the at least one processor, cause the pen cap to communicate with the glucose sensor system via a near field communication protocol when in proximity to at least one part of the glucose sensor system.

### Claim 8 (depends on 7)

The pen cap of claim 7, further comprising instructions that, when executed by the at least one processor, cause the pen cap to transmit messages that are associated with an insulin therapy.

### Claim 9 (depends on 8)

The pen cap of claim 8, wherein the messages comprise indicators, and the indicators are associated with the insulin therapy.

### Claim 10 (depends on 8)

The pen cap of claim 8, further comprising instructions that, when executed by the at least one processor, cause the pen cap to transmit the messages to one or more insulin therapy applications executing at one or more mobile computing devices.

### Claim 11 (depends on 6)

The pen cap of claim 6, further comprising instructions that, when executed by the at least one processor, cause the pen cap to transmit messages by broadcasting advertising messages.

### Claim 12 (depends on 6)

The pen cap of claim 6, further comprising instructions that, when executed by the at least one processor, cause the pen cap to transmit messages using data transmission.

### Claim 13 (depends on 6)

The pen cap of claim 6, further comprising instructions that, when executed by the at least one processor, cause the pen cap to automatically transmit data to an insulin therapy application executing on a mobile device.

### Claim 14 (depends on 6)

The pen cap of claim 6, further comprising instructions that, when executed by the at least one processor, cause the pen cap to automatically communicate with a mobile application.

### Claim 15 (depends on 6)

The pen cap of claim 6, further comprising instructions that, when executed by the at least one processor, cause the pen cap to communicate with the glucose sensor system via a first wireless communication technique having a first communication range and to communicate with a mobile computing device via a second wireless communication technique having a second communication range, the second communication range being greater than the first communication range.

### Claim 16 (depends on 6)

The pen cap of claim 6, wherein the glucose sensor system comprises a flash glucose monitor.

### Claim 17 (depends on 1)

The pen cap of claim 1, further comprising instructions that, when executed by the at least one processor, cause the at least one processor to:
determine 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; and
cause the at least one user interface to display a representation of the percentage of active insulin remaining within the user.

### Claim 18 (depends on 1)

The pen cap of claim 1, further comprising instructions that, when executed by the at least one processor, cause the at least one processor to:
determine an amount of insulin remaining in the manual insulin delivery device;
determine a dose amount for one or more dosing events based at least partially on the amount of insulin remaining in the manual insulin delivery device; and
cause the at least one user interface to display an estimation of active insulin remaining within a user responsive to a current time and the dose amount.

### Claim 19 (depends on 18)

The pen cap of claim 18, further comprising instructions that, when executed by the at least one processor, cause the at least one processor to:
track one or more dosing events over a first time period, the first time period comprising:
a first block of discrete time units;
a start time unit of the first block of discrete time units; and
an end time of the first block of discrete time units,
wherein the end time corresponds to the current time and at least one of the discrete time units is associated with a dosing event of the one or more dosing events.

### Claim 20 (depends on 19)

The pen cap of claim 19, further comprising instructions that, when executed by the at least one processor, cause the at least one processor to: track dosing events responsive to detected capping and/or detected decapping and associate the one or more dosing events with one or more discrete time units of the at least one of the discrete time units.

### Claim 21 (depends on 19)

The pen cap of claim 19, further comprising instructions that, when executed by the at least one processor, cause the at least one processor to:
select a block of discrete time units that form the first time period responsive to an active insulin estimation request and the current time;
select the one or more dosing events that are associated with the first time period; and
determine the estimation of active insulin remaining within the user responsive to the current time and the one or more dosing events.

### Claim 22 (depends on 18)

The pen cap of claim 18, further comprising instructions that, when executed by the at least one processor, cause the at least one processor to: cause the at least one user interface to display the estimation of active insulin remaining as a percentage of the dose amount associated with a most recent dosing action.

### Claim 23 (depends on 1)

The pen cap of claim 1, further comprising an inner sleeve and an outer housing, the inner sleeve and the outer housing defining a water tight cavity.

### Claim 24 (depends on 23)

The pen cap of claim 23, wherein at least a part of one or more of the at least one processor or the at least one non-transitory computer-readable storage medium is at least partially disposed within the water tight cavity.

### Claim 25

An insulin delivery system comprising:
an insulin injection pen for delivering insulin; and
a pen cap adapted to be reversibly secured to the insulin injection pen, the pen cap comprising:
at least one processor; and
at least one non-transitory computer-readable storage medium storing instructions thereon that, when executed by the at least one processor, cause the at least one processor to:
cause at least one user interface to display a recommended correction dose of insulin responsive to a determination that the pen cap has been continuously capped on the insulin injection pen for at least a first threshold period of time.

### Claim 26 (depends on 25)

The insulin delivery system of claim 25, wherein the pen cap further comprises instructions that, when executed by the at least one processor, cause the at least one processor to:
responsive to the pen cap being recapped subsequent to a period of being decapped, determining that the pen cap has been decapped for less than a second threshold period of time; and
responsive to the determination that the pen cap has been decapped for less than a second threshold period of time, determine that the pen cap qualifies as being identified as capped during the period of being decapped in regard to a determination to display the recommended correction dose of insulin.

### Claim 27 (depends on 25)

The insulin delivery system of claim 25, wherein the recommended correction dose of insulin is based at least partially on an insulin sensitivity factor and target glucose value associated with a user.

### Claim 28 (depends on 25)

The insulin delivery system of claim 25, wherein the at least one processor is further adapted to cause the at least one user interface to display 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 29 (depends on 25)

The insulin delivery system of claim 25, further comprising instructions that, when executed by the at least one processor, cause the pen cap to:
determine an amount of insulin remaining in the insulin injection pen and determine a dose amount for the time of a previous capping or decapping; and
display an estimation of active insulin remaining within a user based on a current time and the time and dose amount associated with one or more previous capping or decapping of the pen cap.

### Claim 30

A diabetes management system comprising:
a pen cap adapted to be reversibly secured to an insulin injection pen, the pen cap comprising:
at least one processor; and
at least one non-transitory computer-readable storage medium storing instructions thereon that, when executed by the at least one processor, cause the at least one processor to:
display a recommended correction dose of insulin responsive to a determination that the pen cap has been continuously capped on the insulin injection pen for at least a first threshold period of time.

### Claim 31 (depends on 30)

The diabetes management system of claim 30, wherein the pen cap further comprises instructions that, when executed by the at least one processor, cause the at least one processor to:
responsive to the pen cap being recapped subsequent to a period of being decapped, determining that the pen cap has been decapped for less than a second threshold period of time; and
responsive to the determination that the pen cap has been decapped for less than a second threshold period of time, determine that the pen cap qualifies as being identified as capped during the period of being decapped in regard to a determination to display the recommended correction dose of insulin.

### Claim 32 (depends on 30)

The diabetes management system of claim 30, wherein the recommended correction dose of insulin is based at least partially on an insulin sensitivity factor and target glucose value stored in storage medium.

### Claim 33 (depends on 30)

The diabetes management system of claim 30, further comprising a long-acting insulin pen, a rapid-acting insulin pen, and at least two pen caps, the at least two pen caps including a first pen cap adapted to be secured to the long-acting insulin pen and a second pen cap adapted to be secured to the rapid-acting insulin pen.

### Claim 34 (depends on 30)

The diabetes management system of claim 30, wherein the pen cap further comprises instructions that, when executed by the at least one processor, cause the pen cap to communicate with a glucose sensor system via a near field communication protocol when in proximity to at least one part of the glucose sensor system.

### Claim 35 (depends on 30)

The diabetes management system of claim 30, wherein the pen cap further comprises instructions that, when executed by the at least one processor, cause the pen cap to communicate with a glucose sensor system via a first wireless communication technique having a first communication range and to communicate with a mobile computing device via a second wireless communication technique having a second communication range, the second communication range being greater than the first communication range.

### Claim 36 (depends on 35)

The diabetes management system of claim 35, wherein the glucose sensor system comprises a flash glucose monitor.

### Claim 37

A smart electronics module integratable with a manual insulin delivery device, comprising:
at least one processor; and
at least one non-transitory computer-readable storage medium storing instructions thereon that, when executed by the at least one processor, cause the at least one processor to:
cause at least one user interface of the smart electronics module to display a recommended correction dose of insulin responsive to a determination that the smart electronics module has been continuously capped on the manual insulin delivery device for at least a first threshold period of time.

### Claim 38 (depends on 37)

The module of claim 37, further comprising instructions that, when executed by the at least one processor, cause the module to: receive glucose measurement data from glucose sensor system and via a wireless communication interface.

### Claim 39 (depends on 38)

The module of claim 38, wherein the glucose measurement data is an interstitial fluid glucose level or based on an interstitial fluid glucose level.

### Claim 40 (depends on 38)

The module of claim 38, wherein the glucose measurement data is a blood glucose level correlated to an interstitial fluid glucose level.

### Claim 41 (depends on 38)

The module of claim 38, wherein the glucose measurement data is a blood glucose level.