Fluid dispensing device with a flow detector

• US 9,227,010 B2
• Filed: 04/29/2013
• Issued: 01/05/2016
• Est. Priority Date: 11/01/2010
• Status: Active Grant

• Current Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Neta, Avraham, Tsypko, Konstantin, Tsypko, Nikolay, Yodfat, Ofer
• Primary Examiner(s): VU, QUYNH-NHU HOANG
• Application Number:
  US13/872,938
• Publication Number:
  US 20130237955A1
• Time in Patent Office: 981 Days
• Field of Search: 604/113, 604/67
• US Class Current: 1/1
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2005/16863 Occlusion detection
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons
• CPC Class Codes: 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
• CPC Class Codes: A61M 5/16886 for measuring fluid flow rate, i.e. flowmeters
• CPC Class Codes: A61M 5/365 Air detectors A61M5/1684 takes precedence; in extracorporeal blood circuits A61M1/3626

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

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 comprising,

a driving mechanism, the driving mechanism including a rotary motor and at least one gear;

a flow detector comprising at least one heating element and at least two temperature sensors, and

a processor;

a second part comprising,

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 at least one heating element and the at least two temperature sensors touch the delivery tube, and wherein the processor, upon activation of the at least one heating element, detects a flow condition of the therapeutic fluid inside the delivery tube based on a signal provided by the at least two temperature sensors; and

wherein the rotary motor is configured to automatically adjust motor operation in a positive or negative feedback, so that the fluid delivery device is configured to adjust or control delivery of the therapeutic fluid through the delivery tube based, at least in part, on the determined flow rate such that the therapeutic fluid is delivered at substantially a pre-determined delivery rate.

2. The fluid delivery device according claim 1, wherein the fluid delivery device determines a temperature gradient within the therapeutic fluid and determines the flow condition based on the temperature gradient.

3. 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.

4. 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.

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

6. 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.

7. The fluid delivery device according to claim 6, wherein the drug dispensing unit comprising a blood glucose sensing apparatus.

8. 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.

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

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

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

12. The fluid delivery device according to claim 11, further comprising, a subcutaneous insertable tip, wherein the subcutaneous insertable tip serves both as therapeutic fluid cannula and sensing probe.

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

14. The fluid delivery device according to claim 13, 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.

15. The fluid delivery device according to claim 1, wherein the fluid delivery device delivers power to the at least one heating element, suspends power delivery to the at least one heating element, and delivers power to the motor to begin motor operation subsequent to the suspension of power delivery to the at least one heating element, wherein the power delivered to the motor causes heated therapeutic fluid to flow into the delivery tube.

16. The fluid delivery device according to claim 1, further comprising,

a capacitor, and

a power supply, wherein the fluid delivery device periodically charges the capacitor via the power supply and periodically discharges the capacitor by operating the motor.

17. The fluid delivery device according to claim 16, wherein the fluid delivery device periodically discharges the capacitor by powering the at least one heating element.

18. The fluid delivery device according to claim 16, wherein the delivery device sequentially discharges the capacitor by powering the at least one heating element and operating a motor and recharges the capacitor between operating the motor and powering the at least one heating element.

19. The fluid delivery device according to claim 1, further comprising, a revolution counter;

wherein the processor is coupled to a motor and generates and provides pulses to the motor for powering 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.

20. The fluid delivery device according to claim 19, wherein the delivery device, upon sequential operations of the motor and the flow detector, detects air bubbles within the delivery tube and/or an occlusion in the delivery tube.

21. The fluid delivery device according to claim 1, wherein the at least one heating element is proximate to the delivery tube at a first location, wherein the at least one heating element is arranged to directly heat the delivery tube to cause heating of the therapeutic fluid in the delivery tube and a first upstream temperature sensor is placed upstream of the first location and a second downstream temperature sensor is placed downstream of the first location.

22. The fluid delivery device according to claim 21, wherein the fluid delivery device determines the flow condition of the therapeutic fluid within the delivery tube based, at least in part, on temperature measurements performed by the upstream temperature sensor and the downstream temperature sensor.

23. The fluid delivery device according to claim 22, wherein the flow detector further comprises an alignment rack holding the at least one heating element, the at least one upstream temperature sensor, and the at least one downstream temperature sensor;

and wherein the alignment rack aligns the heating element, the at least one upstream temperature sensor, and the at least one downstream temperature sensor with the delivery tube.

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

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