# US 11,298,470 B2 · Methods and apparatus for improved medication delivery devices

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- Number: US 11,298,470 B2
- Document ID: US11298470B2
- Status: Granted
- Kind: B2
- Application number: 16/345,706
- Filed: 2017-10-26
- Published: 2019-11-21
- Granted: 2022-04-12
- Earliest claimed: 2016-10-28
- Assignees: Ascensia Diabetes Care Holdings AG
- Applicants: Ascensia Diabetes Care Holdings AG
- Inventors: Nikhil M. Shah; Eugene R. Prais; Nihir Patel; Jennifer L. Gass; Megan M. Burkarski
- Web page: https://patentgrep.com/patent/US11298470B2

## CPC

- A61M 5/31525: {Dosing (burettes, pipettes B01L3/02)}
- A61M 5/5086: {for indicating if defective, used, tampered with or unsterile}
- A61M 5/31528: {by means of rotational movements, e.g. screw-thread mechanisms}
- A61M 5/31551: {including axial movement of dose setting member}
- A61M 2205/18: with alarm
- A61M 2205/33: Controlling, regulating or measuring
- A61M 2205/3317: Electromagnetic, inductive or dielectric measuring means
- A61M 2205/3327: Measuring
- A61M 2205/3334: Measuring or controlling the flow rate
- A61M 2205/3368: Temperature
- A61M 2205/35: Communication
- 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 2205/3592: using telemetric means, e.g. radio or optical transmission
- A61M 2205/50: with microprocessors or computers
- A61M 2205/52: with memories providing a history of measured variating parameters of apparatus or patient
- A61M 2205/581: by audible feedback
- A61M 2205/584: having a color code
- A61M 2205/587: Lighting arrangements
- 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)}

## Abstract

Embodiments provide systems, methods, and apparatus for a medication delivery device. The device includes a dose selector for selecting an amount of medication to deliver; a first capacitive sensor adjacent the dose selector and operative to detect linear displacement of the dose selector during medication delivery; a screw coupled to the dose selector; a second capacitive sensor adjacent the screw and operative to detect linear displacement of the screw during medication delivery; and a processor coupled to the first and second capacitive sensors and operative to determine an amount of medication actually delivered by the medication delivery device. Numerous other aspects are provided.

## Claims

### Claim 1

A medication delivery device comprising:
a dose selector for selecting an amount of medication to deliver;
a first capacitive sensor adjacent the dose selector and operative to detect linear displacement of the dose selector during medication delivery;
a screw coupled to the dose selector;
a second capacitive sensor adjacent the screw and operative to detect linear displacement of the screw during medication delivery;
a transceiver; and
a processor coupled to the first capacitive sensor, the second capacitive sensor, and the transceiver and operative to determine an amount of medication actually delivered by the medication delivery device based on a comparison of determined amounts of medication via the detected linear displacement of the dose selector and the detected linear displacement of the screw, wherein a variation in the determined amounts of medication greater than a predetermined limit sets off an alert to a user that the medication delivery device is no longer operating accurately, the processor further operative to communicate via the transceiver the determined amount of medication from the medication delivery device to a data management system or a blood glucose meter.

### Claim 2 (depends on 1)

The medication delivery device of claim 1, wherein the dose selector is rotatable for selecting an amount of medication to deliver.

### Claim 3 (depends on 1)

The medication delivery device of claim 1, wherein the processor is operative to record information related to the determined amount of medication.

### Claim 4 (depends on 3)

The medication delivery device of claim 3, wherein the information related to the determined amount of medication includes at least one of:
a time and date a dose was administered;
a rate at which the dose was administered;
a time and date a needle of the medication delivery device was installed or removed;
a time and date a medication cartridge of the medication delivery device was inserted or removed; and
a temperature reading.

### Claim 5 (depends on 3)

The medication delivery device of claim 3, wherein the processor is further operative via the transceiver to communicate the recorded information from the medication delivery device to the data management system or the blood glucose meter.

### Claim 6 (depends on 1)

The medication delivery device of claim 1, further comprising an indicator, wherein the processor is operative to activate the indicator in response to at least one of an improper amount of medication having been delivered by the medication delivery device or a needle of the medication delivery device requiring replacement.

### Claim 7 (depends on 6)

The medication delivery device of claim 6, wherein the indicator comprises a sound generation device or an LED.

### Claim 8 (depends on 1)

The medication delivery device of claim 1, wherein the transceiver comprises a radio frequency transceiver or a Bluetooth® transceiver.

### Claim 9 (depends on 1)

The medication delivery device of claim 1, further comprising a clock coupled to the processor.

### Claim 10 (depends on 1)

The medication delivery device of claim 1, further comprising a follower with a stator track mounted adjacent the dose selector, wherein the first capacitive sensor detects linear displacement of the dose selector during medication delivery via a stator plate on the follower moving past the first capacitive sensor.

### Claim 11 (depends on 1)

The medication delivery device of claim 1, further comprising a device body and a medication cartridge holder, wherein the medication cartridge holder is reusable, detachably coupled to the device body, and comprises the second capacitive sensor.

### Claim 12 (depends on 1)

The medication delivery device of claim 1, further comprising a circuit board housing having a circuit board therein and a thermal sensor mounted on the circuit board.

### Claim 13 (depends on 12)

The medication delivery device of claim 12, wherein the processor is further operative to record ambient temperatures that the medication delivery device is exposed to as detected by the thermal sensor.

### Claim 14 (depends on 13)

The medication delivery device of claim 13, further comprising an indicator, wherein the processor is further operative to activate the indicator in response to the medication delivery device being exposed to an extreme temperature as detected by the thermal sensor.

### Claim 15 (depends on 14)

The medication delivery device of claim 14, wherein the indicator comprises an LED.

### Claim 16

A method of delivering a medication with a medication delivery device comprising:
selecting an amount of medication to deliver via a dose selector;
detecting linear displacement of the dose selector during medication delivery via a first capacitive sensor adjacent the dose selector;
detecting linear displacement of a screw coupled to the dose selector during medication delivery via a second capacitive sensor adjacent the screw; and
determining an amount of medication actually delivered by the medication delivery device via a processor coupled to the first and second capacitive sensors based on a comparison of determined amounts of medication via the detected linear displacement of the dose selector and the detected linear displacement of the screw, wherein a variation in the determined amounts of medication greater than a predetermined limit sets off an alert to a user that the medication delivery device is no longer operating accurately.

### Claim 17 (depends on 16)

The method of claim 16, wherein the selecting comprises rotating the dose selector to select an amount of medication to deliver.

### Claim 18 (depends on 16)

The method of claim 16, further comprising recording information from various sensors using the processor.

### Claim 19 (depends on 18)

The method of claim 18, wherein the recording of information comprises recording at least one of:
a time and date a dose was administered;
a rate at which the dose was administered;
a time and date a needle of the medication delivery device was installed or removed;
a time and date a medication cartridge of the medication delivery device was inserted or removed; and
a temperature reading.

### Claim 20 (depends on 18)

The method of claim 18, further comprising communicating the recorded information from the medication delivery device to a data management system or a blood glucose meter.
