# US 10,503,876 B2 · Methods and apparatus for enhancing a medication delivery device

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- Number: US 10,503,876 B2
- Document ID: US10503876B2
- Status: Granted
- Kind: B2
- Application number: 15/125,143
- Filed: 2015-02-17
- Published: 2016-12-29
- Granted: 2019-12-10
- Earliest claimed: 2014-03-12
- Assignees: Ascensia Diabetes Care Holdings AG
- Applicants: Ascensia Diabetes Care Holdings AG
- Inventors: Igor Y. Gofman; Jun Chen; James A. Johnson
- Web page: https://patentgrep.com/patent/US10503876B2

## CPC

- A61M 5/31546: {Electrically operated dose setting, e.g. input via touch screen or plus/minus buttons}
- A61M 5/009: {Electronic or electro-mechanical add-on modules}
- A61M 5/20: Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically (A61M5/142 takes precedence)
- A61M 5/31528: {by means of rotational movements, e.g. screw-thread mechanisms}
- G16H 20/17: delivered via infusion or injection
- A61M 5/31551: {including axial movement of dose setting member}
- A61M 2205/18: with alarm
- A61M 2205/35: Communication
- A61M 2205/3569: sublocal, e.g. between console and disposable
- A61M 2205/3584: using modem, internet or Bluetooth®
- A61M 2205/3592: using telemetric means, e.g. radio or optical transmission
- A61M 2205/50: with microprocessors or computers
- A61M 2205/502: User interfaces, e.g. screens or keyboards
- A61M 2205/52: with memories providing a history of measured variating parameters of apparatus or patient
- A61M 2205/581: by audible feedback
- A61M 2205/583: by visual feedback
- A61M 2205/6072: Bar codes
- A61M 2209/01: Remote controllers for specific apparatus
- A61M 2230/005: Parameter used as control input for the apparatus
- 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)}
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

Embodiments of the invention provide systems, methods, and apparatus for attaching an automated dose setting apparatus to a medication delivery device, receiving a first signal from an analyte monitoring system, the first signal indicating a dose of medication to be administered, and driving a dose knob of the medication delivery device with the automated dose setting apparatus to set a dose corresponding with the dose of medication to be administered. Numerous other aspects are disclosed.

## Claims

### Claim 1

An apparatus, comprising:
a first portion coupleable onto a top of a manually-operated dose knob of a medication delivery device; and
a second portion coupled to the first portion and coupleable onto a top of a housing of the medication delivery device,
wherein the second portion is operable to receive dose information electronically from an external device and to drive the first portion to operate the dose knob to set a dosage of the medication delivery device.

### Claim 2 (depends on 1)

The apparatus of claim 1 further comprising an electronic circuit contained in the second portion and wherein the electronic circuit includes a controller, a driver assembly, and a transceiver.

### Claim 3 (depends on 2)

The apparatus of claim 2 wherein the driver assembly includes two actuators operable to rotate the first portion.

### Claim 4 (depends on 2)

The apparatus of claim 2 wherein the electronic circuit further includes a sensor assembly operable to detect rotation of the first portion.

### Claim 5 (depends on 1)

The apparatus of claim 1 wherein the first portion includes a cylinder shaft having tooth fluting.

### Claim 6 (depends on 5)

The apparatus of claim 5 wherein the second portion includes a driver assembly operable to rotate the cylinder shaft using alternating linear actuators.

### Claim 7 (depends on 1)

The apparatus of claim 1 wherein the second portion includes a display operable to indicate a dosage setting of the medication delivery device.

### Claim 8

A method, comprising:
attaching an automated dose setting apparatus onto a top of a medication delivery device;
receiving a first signal from an external analyte monitoring system, the first signal indicating a dose of medication to be administered; and
driving a manually-operated dose knob of the medication delivery device with the automated dose setting apparatus to set a dose corresponding with the dose of medication to be administered.

### Claim 9 (depends on 8)

The method of claim 8 further comprising:
monitoring movement of the medication delivery device while the dose knob is driven by the automated dose setting apparatus; and
verifying that the dose set by the automated dose setting apparatus corresponds with the dose of medication to be administered.

### Claim 10 (depends on 8)

The method of claim 8 further comprising:
monitoring movement of the medication delivery device while the medication is being administered; and
verifying that a dose of medication actually administered corresponds with the dose of medication to be administered.

### Claim 11 (depends on 10)

The method of claim 10 further comprising:
providing an indication if the dose of medication actually administered corresponds with the dose of medication to be administered; and
providing an alarm if the dose of medication actually administered does not correspond with the dose of medication to be administered.

### Claim 12 (depends on 8)

The method of claim 8 further comprising:
transmitting a second signal to the analyte monitoring system from the automated dose setting apparatus, the second signal indicating a dose of medication actually administered.

### Claim 13 (depends on 8)

The method of claim 8 wherein attaching an automated dose setting apparatus to a medication delivery device includes coupling a first portion of the automated dose setting apparatus to the dose knob of the medication delivery device.

### Claim 14 (depends on 8)

The method of claim 8 wherein attaching an automated dose setting apparatus to a medication delivery device includes coupling a second portion of the automated dose setting apparatus to a housing of the medication delivery device.

### Claim 15 (depends on 8)

The method of claim 8 wherein driving a dose knob of the medication delivery device includes rotating a first portion of the automated dose setting apparatus coupled to the dose knob by driving the first portion using a driver assembly in a second portion of the automated dose setting apparatus that is coupled to a housing of the medication delivery device.

### Claim 16 (depends on 15)

The method of claim 15 wherein driving the first portion using a driver assembly in the second portion of the automated dose setting apparatus includes rotating the first portion using alternating linear actuators.

### Claim 17

An apparatus, comprising:
a first portion coupleable onto a top of a manually-operated dose knob of a medication delivery device, the first portion movable to operate the dose knob; and
a second portion coupled to the first portion and coupleable onto a top of a housing of the medication delivery device,
wherein the second portion is operable to monitor movement of the first portion and to transmit a signal electronically to an external device indicative of a dose of medication administered with the medication delivery device.

### Claim 18 (depends on 17)

The apparatus of claim 17 wherein the first portion includes a transparent cylinder shaft operable to surround a dose stem of the medication delivery device.

### Claim 19 (depends on 18)

The apparatus of claim 18 wherein the cylinder shaft includes at least one set of dosage indicator markings detectable by a sensor assembly within the second portion.

### Claim 20 (depends on 17)

The apparatus of claim 17 wherein the first portion is rotatably coupleable to the second portion.
