# US 12,224,050 B2 · Control of medical device using wireless communication

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- Number: US 12,224,050 B2
- Document ID: US12224050B2
- Status: Granted
- Kind: B2
- Application number: 16/760,026
- Filed: 2018-10-31
- Published: 2020-09-17
- Granted: 2025-02-11
- Earliest claimed: 2017-10-31
- Assignees: Novo Nordisk A/S
- Applicants: Novo Nordisk A/S
- Inventors: Christian Peter Enggaard; Rune Ravn
- Web page: https://patentgrep.com/patent/US12224050B2

## CPC

- A61M 5/178: Syringes
- G16H 20/17: delivered via infusion or injection
- A61M 5/20: Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically (A61M5/142 takes precedence)
- A61M 5/31535: {Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose}
- A61M 5/31546: {Electrically operated dose setting, e.g. input via touch screen or plus/minus buttons}
- A61M 5/3159: {Dose expelling manners}
- G16H 40/67: for remote operation
- A61M 5/31571: {Means preventing accidental administration (for automatic syringes A61M5/20)}
- A61M 5/31573: {Accuracy improving means}
- A61M 2005/3125: {Display means, e.g. to indicate dose setting}
- A61M 2205/18: with alarm
- A61M 2205/276: preventing unwanted use
- A61M 2205/3553: remote, e.g. between patient's home and doctor's office
- A61M 2205/3561: local, e.g. within room or hospital
- A61M 2205/3569: sublocal, e.g. between console and disposable
- A61M 2205/3584: using modem, internet or Bluetooth®
- A61M 2205/50: with microprocessors or computers
- A61M 2205/581: by audible feedback
- A61M 2205/582: by tactile feedback
- A61M 2205/583: by visual feedback
- A61M 2205/6009: for matching patient with his treatment, e.g. to improve transfusion security
- 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)}
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

The present invention provides a system (1) comprising: a pen injection device (10) holding a specific type of medicament and comprising a dose expelling mechanism and pen communication means (15), a mobile communication unit (30) comprising mobile communication means (35) adapted to communicate with the pen communication means (15), and a software application program configured to determine a recommended type of medicament to be delivered to a user based on information indicative of a physiological condition of the user, wherein the pen injection device (10) further comprises indication means which in a first state indicates that the dose expelling mechanism is to remain idle and in a second state indicates that the dose expelling mechanism is available for operation, and wherein the mobile communication unit (30) is configured to, via a communication from the mobile communication means (35) to the pen communication means (15), a) prompt a change of state of the indication means from the second state to the first state in response to the recommended type of medicament to be delivered differing from the specific type of medicament, and/or b) prompt a change of state of the indication means from the first state to the second state in response to the recommended type of medicament to be delivered corresponding to the specific type of medicament.

## Claims

### Claim 1

A pen injection safety system having two-way communication between a mobile communication unit and at least two pen injection devices, the system comprising:
a first pen injection device holding a first specific type of medicament and comprising:
a first dose expelling mechanism,
a first pen communication structure, and
a first indication structure which in a first state indicates that the first dose expelling mechanism is to remain idle and in a second state indicates that the first dose expelling mechanism is available for operation,
a second pen injection device holding a second specific type of medicament and comprising:
a second dose expelling mechanism,
a second pen communication structure, and
a second indication structure which in a first state indicates that the second dose expelling mechanism is to remain idle and in a second state indicates that the second dose expelling mechanism is available for operation,
the mobile communication unit comprising mobile communication structure adapted for two-way communication with each of the first pen communication structure and the second pen communication structure, and
a software application program configured to determine a recommended type of medicament to be delivered to a user as one of the first specific type of medicament and the second specific type of medicament based on information indicative of a physiological condition of the user,
wherein the mobile communication unit is configured to, via a communication from the mobile communication structure to at least one of the first pen communication structure and the second pen communication structure,
prompt a change of state of the first indication structure from the second state to the first state and/or a change of state of the second indication structure from the first state to the second state in response to the recommended type of medicament to be delivered being the second specific type of medicament, and
prompt a change of state of the second indication structure from the second state to the first state and/or a change of state of the first indication structure from the first state to the second state in response to the recommended type of medicament to be delivered being the first specific type of medicament,
thereby providing a pen injection safety system reducing the risk of the user inadvertently administering medicament which differs from the recommended type of medicament.

### Claim 2 (depends on 1)

The pen injection safety system according to claim 1, wherein the software application program is configured to determine the recommended type of medicament to be delivered based at least in part on information sent from the first pen communication structure to the mobile communication structure.

### Claim 3 (depends on 1)

The pen injection safety system according to claim 1, wherein the first pen injection device further comprises a dose setting mechanism operable to set a dose to be delivered.

### Claim 4 (depends on 3)

The pen injection safety system according to claim 3, wherein prompting a change of state of the first indication structure from the second state to the first state comprises disabling the dose setting mechanism.

### Claim 5 (depends on 3)

The pen injection safety system according to claim 3, wherein the first pen injection device further comprises a dose display for visual confirmation of a set dose, and wherein prompting the change of state of the first indication structure from the second state to the first state comprises affecting the dose display.

### Claim 6 (depends on 3)

The pen injection safety system according to claim 3, wherein the mobile communication unit further comprises an alert generator adapted emit an alert signal, wherein the first pen communication structure is configured to register and to notify the mobile communication structure of an ongoing operation of the dose setting mechanism, and wherein the alert generator is configured to emit the alert signal, if the mobile communication structure receives a notification from the first pen communication structure and the recommended type of medicament is the second specific type of medicament.

### Claim 7 (depends on 1)

The pen injection safety system according to claim 1, wherein the first pen injection device further comprises a sound generator, and wherein prompting the change of state of the first indication structure from the second state to the first state comprises producing a notifying sound via the sound generator.

### Claim 8 (depends on 1)

The pen injection safety system according to claim 1, wherein prompting the change of state of the first indication structure from the second state to the first state comprises disabling the first dose expelling mechanism.

### Claim 9 (depends on 1)

The pen injection safety system according to claim 1, wherein the mobile communication unit further comprises an alert generator adapted emit an alert signal, wherein the first pen communication structure is configured to register and to notify the mobile communication structure of an ongoing operation of the first dose expelling mechanism, and wherein the alert generator is configured to emit the alert signal, if the mobile communication structure receives a notification from the first pen communication structure and the recommended type of medicament is the second specific type of medicament.

### Claim 10 (depends on 1)

The pen injection safety system according to claim 1, wherein the recommended type of medicament is selected from a group consisting of a) a first type of diabetes medication and b) a second type of diabetes medication.

### Claim 11 (depends on 10)

The pen injection safety system according to claim 10, wherein the first type of diabetes medication is a rapid acting insulin and the second type of diabetes medication is a long acting insulin.

### Claim 12 (depends on 1)

The pen injection safety system according to claim 1, wherein prompting a change of state of the first indication structure from the first state to the second state comprises providing a visual, audible and/or tactile signal that the first pen injection device is ready to be used.