# US 11,077,244 B2 · Fluid dispensing device with a flow detector

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- Number: US 11,077,244 B2
- Document ID: US11077244B2
- Status: Granted
- Kind: B2
- Application number: 16/151,785
- Filed: 2018-10-04
- Published: 2019-01-31
- Granted: 2021-08-03
- Earliest claimed: 2010-11-01
- Assignees: Roche Diabetes Care, Inc.
- Applicants: Roche Diabetes Care, Inc.
- Inventors: Avraham Neta; Konstantin Tsypko; Nikolay Tsypko; Ofer Yodfat
- Web page: https://patentgrep.com/patent/US11077244B2

## CPC

- A61M 5/14244: {adapted to be carried by the patient, e.g. portable on the body}
- A61M 5/14248: {of the skin patch type}
- A61M 5/16831: {Monitoring, detecting, signalling or eliminating infusion flow anomalies (low-level float-valves causing cut-off A61M5/40; indicating or recording presence, absence or direction of flow in general G01P13/0066)}
- A61M 5/16886: {for measuring fluid flow rate, i.e. flowmeters}
- A61M 5/1452: {pressurised by means of pistons}
- A61M 5/16863: {Occlusion detection}
- A61M 5/365: {Air detectors (A61M5/1684 takes precedence; in extracorporeal blood circuits A61M1/3626)}
- A61M 2005/14268: {with a reusable and a disposable component}
- A61M 2205/3334: Measuring or controlling the flow rate
- A61M 2205/3368: Temperature
- 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

A portable therapeutic fluid delivery device with a flow detector comprising a heating element and two temperature sensors is presented. Upon activation of the heating element, a flow condition of the fluid inside the delivery tube is determined based on a signal provided by the temperature sensors. A temperature gradient within the therapeutic fluid is detected. The determined flow condition can be one of: air bubbles within the delivery tube, occlusion within the delivery tube, or leakage within the delivery tube. The device can have two parts, for example, a reusable part and a disposable part. Upon pairing of these parts, the heating element and the temperature sensors touch the delivery tube.

## Claims

### Claim 1

A portable therapeutic fluid delivery device for delivering a therapeutic fluid into a body of a patient, the fluid delivery device comprising:
a first part which comprises:
a driving mechanism,
a processor,
a flow detector comprising two electronic components electrically coupled to the processor; and
a second part which comprises:
a reservoir,
an exit port, and
a delivery tube communicating between the reservoir and the exit port,
wherein the first part and the second part are designed such that upon pairing of the first part with the second part, the two electronic components of the flow detector are thermally coupled to the delivery tube, and upon activation of a first one of the two electronic component to heat the delivery tube, the processor is configured to determine flow condition of the therapeutic fluid inside the delivery tube based on sensed temperature provided to the processor by a second one of the two electronic components.

### Claim 2 (depends on 1)

The fluid delivery device according claim 1, wherein the delivery device adjusts or controls delivery of the therapeutic fluid through the delivery tube based, at least in part, on a determined flow rate such that the therapeutic fluid is delivered at a pre-determined delivery rate.

### Claim 3 (depends on 1)

The fluid delivery device according claim 1, further comprising a motor, wherein the processor controls the motor to keep delivery of the therapeutic fluid through the delivery tube at a pre-determined delivery rate.

### Claim 4 (depends on 1)

The fluid delivery device according claim 1, further comprising a motor, wherein the processor controls the motor to keep delivery of the therapeutic fluid through the delivery tube at a pre-determined delivery rate based, at least in part, on a determined flow rate.

### Claim 5 (depends on 1)

The fluid delivery device according claim 1, wherein the first one of the two electronic components is a heating element and the second one of the two electronic components is a temperature sensor.

### Claim 6 (depends on 1)

The fluid delivery device according claim 1, wherein the second one of the two electronic components is a temperature sensor selected from a temperature-sensitive resistor, a thermistor, and a silistor.

### Claim 7 (depends on 1)

The fluid delivery device according to claim 1, wherein the flow condition includes at least one of: air bubbles within the delivery tube, an occlusion within the delivery tube, a leakage within the delivery tube, or combinations thereof.

### Claim 8 (depends on 1)

The fluid delivery device according to claim 1, wherein the fluid delivery device alerts the patient to conditions of occlusion, air bubbles, leakage in the delivery tube or combinations thereof.

### Claim 9 (depends on 1)

The fluid delivery device according to claim 1, wherein the fluid delivery device is remotely controlled.

### Claim 10 (depends on 1)

The fluid delivery device according to claim 1, wherein the fluid delivery device comprises a skin securable drug dispensing unit, the drug dispensing unit comprises the first part and the second part.

### Claim 11 (depends on 1)

The fluid delivery device according to claim 1, wherein the fluid delivery device comprises a blood glucose sensing apparatus.

### Claim 12 (depends on 1)

The fluid delivery device according to claim 1, wherein the fluid delivery device comprises a skin securable drug dispensing unit comprising buttons, and wherein the drug dispensing unit is operated manually using the buttons.

### Claim 13 (depends on 1)

The fluid delivery device according to claim 1, wherein the fluid delivery device disconnects from and reconnects to a skin adherable cradle unit.

### Claim 14 (depends on 1)

The fluid delivery device according to claim 1, wherein the first part or the second part comprises an energy supply.

### Claim 15 (depends on 1)

The fluid delivery device according to claim 1, further comprising a handheld remote control unit which comprises an integrated blood glucose monitor.

### Claim 16 (depends on 1)

The fluid delivery device according to claim 1, further comprising a subcutaneous insertable tip, wherein the subcutaneous insertable tip serves both as a therapeutic fluid cannula and a sensing probe.

### Claim 17 (depends on 1)

The fluid delivery device according to claim 1, wherein the driving mechanism comprises a motor.

### Claim 18 (depends on 17)

The fluid delivery device according to claim 17, further comprising a pulse generator coupled to the motor to operate the motor, wherein the fluid delivery device detects an occlusion by detecting a mismatch between pulses supplied to the motor and motor operation.

### Claim 19 (depends on 17)

The fluid delivery device according to claim 17, wherein the fluid delivery device is configured to deliver power to the first one of the two electronic components, suspend power delivery to the first one of the two electronic components, and deliver power to the motor to begin motor operation subsequent to the suspension of power delivery to the first one of the two electronic components.

### Claim 20 (depends on 17)

The fluid delivery device according to claim 17, further comprising a capacitor and a power supply, wherein the fluid delivery device is configured to periodically charge the capacitor via the power supply and periodically discharge the capacitor by operating the motor.

### Claim 21 (depends on 20)

The fluid delivery device according to claim 20, wherein the fluid delivery device is configured to periodically discharge the capacitor by powering the first one of the two electronic components.

### Claim 22 (depends on 1)

The fluid delivery device according to claim 1, further comprising a revolution counter and a motor operably controlled by the processor, wherein the processor provides pulses to the motor to power the motor, and wherein the fluid delivery device detects an occlusion if the flow detector determines a condition of no flow in the delivery tube and there is a mismatch between pulses generated by the processor and a predicted number of motor revolutions from the revolution counter.

### Claim 23 (depends on 1)

The fluid delivery device according to claim 1, wherein the delivery tube is elastic or flexible.

### Claim 24 (depends on 1)

The fluid delivery device according to claim 1, wherein the delivery device, in response to a determination that there is no fluid flow, is configured to identify one or more of several possible problems causing a condition of no fluid flow, the several possible problems comprise a missing pulse of motor operation, the reservoir of the therapeutic fluid being empty, presence of air bubbles n the delivery tube, occlusion occurring in the delivery tube and combinations thereof.
