System and Method for Measuring Delivered Dose

• US 20180036495A1
• Filed: 08/02/2016
• Published: 02/08/2018
• Est. Priority Date: 08/02/2016
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Searle, Gary, Burke, Andrew, Costello, Peter, Focht, Kenneth, Ross, Francis L.
• Granted Patent: US 10,052,441 B2
• Time in Patent Office: Days
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 5/16804 Flow controllers
• 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 5/20 Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically A61M5/142 , A61M5/46 take precedence; hypodermic projectiles F42B12/54
• CPC Class Codes: A61M 5/3286 Needle tip design, e.g. for improved penetration
• CPC Class Codes: A61M 5/482 Varying injection pressure, e.g. by varying speed of injection

Abstract

A flow sensor is provided to enable volumetric dose data to be acquired automatically by sampling flow rates of insulin measured by a flow sensor exposed to a flow manifold though which the insulin flows. The flow sensor preferably connects to a standard insulin pen on one end, and to a standard pen needle on the other end. Particular geometries and algorithms are utilized to accommodate the unique requirements of insulin flow determination during an injection event.

Claims

1. A flow sensor system comprising:

a durable portion comprising

an outer housing having a first opening to receive an injection device, and a second opening at an opposite end to receive a semi-disposable portion;

a durable portion electrical connector;

a memory;

a battery;

a processor for receiving and processing signals received from the semi-disposable portion, and for driving the wireless transceiver to send and receive communication signals from the remote device;

a semi-disposable portion comprising;

a first end having a cannula adapted to pierce a septum of the injection device and a female thread adapted to engage a male thread feature of the injection device;

a second end opposite the first end having a male pen needle thread and septum adapted to receive a pen needle;

a printed circuit board having mounted thereon a flow sensor chip;

a manifold in fluid communication with the cannula and the septum, the manifold comprising a continuous flow channel extending from the first end cannula to a chamber adjacent the second end septum, the flow channel comprising an opening to receive a sensor; and

a semi-disposable portion electrical connector for electrical connection to the durable portion electrical connector;

wherein the flow sensor chip comprises a sensing surface adapted to be received in the flow channel opening and exposed within the flow channel;

the sensor surface having a heating element and at least one sensing element downstream of the heating element.

2. The flow sensor system of claim 1, wherein the semi-disposable portion further comprises a deformable locking element that deforms to permit the semi-disposable portion to be installed into the durable portion, and locks the semi-disposable portion into the durable portion once fully installed.

3. The flow sensor system of claim 1, wherein the semi-disposable portion further comprises an alignment feature to align the semi-disposable portion with the durable portion.

4. The flow sensor system of claim 1, wherein the flow sensing chip further comprises a second sensing element upstream of the heating element.

5. The flow sensor system of claim 4, wherein the first sensing element and the second sensing element are equidistant from the heating element.

6. The flow sensor system of claim 1, wherein the semi-disposable portion comprises an alignment feature to align the semi-disposable portion to the durable portion, and a snap flexure to lock the semi-disposable portion within the durable portion once inserted.

7. The flow sensor system of claim 1, wherein the manifold has a first portion with a first cross sectional area, and a second portion with a second cross sectional area, and wherein the flow sensor chip is exposed to the first manifold portion, and a second sensor chip is exposed to the second manifold portion.

8. The flow sensor system of claim 4, wherein the flow sensing chip further comprises a secondary pair of sensing elements spaced equidistantly from the heating element at a second distance upstream and downstream of the heating element, the second distance being different than the distance from the heating element to the at least one sensing element and the second sensing element.

9. The flow sensor system of claim 1, wherein the heating element and the sensing element are electrically connected to the electrical connector.

10. The flow sensor system of claim 9, wherein the electrical connection is made by wire bonding on a conductive pad that is adjacent to and connected to the sensing surface.

11. The flow sensor system of claim 9, wherein the electrical connection is made by conductive material within a plurality of vias providing electrical connection from the sensing surface to an opposite surface of the sensing chip.

12. The flow sensor system of claim 1, wherein the electrical connector of the semi-disposable portion is oriented such that the semi-disposable portion becomes electrically connected to the durable portion when the first end cannula pierces the septum of the injection device.

13. The flow sensor system of claim 1, wherein the durable portion further comprises a wireless transceiver for communicating with a remote device.

15. The method of claim 13, wherein the heating signal is time varying.

14. A method of measuring a dose of medicament delivered through a cannula with a sensor comprising a heating element and a first pair of sensing elements comprising an upstream sensing element and a downstream sensing element, the pair of sensing elements spaced at a first offset distance equidistantly upstream and downstream of the heating element, comprising the steps of:

generating a heating signal with the heating element;

detecting the beginning of medicament flow by sensing a difference in signals received from the upstream and downstream sensing elements;

periodically sampling the upstream and downstream sensing elements to measure instantaneous flow rates;

determining an end of medicament flow;

determining a dose volume based on a plurality of sampled instantaneous flow rates; and

storing the determined dose volume in a memory unit.

16. The method of claim 14, wherein the determining a dose volume step comprising integrating substantially all of the sampled instantaneous flow rates over the duration of the medicament flow.

17. The method of claim 14, wherein the determining a dose volume step comprises matching a set of sampled flow rates to one of a plurality of flow rate templates stored in a table of a memory, each template being associated with a different dose volume.

18. The method of claim 14, wherein the sensor comprises a second pair of upstream and downstream sensing elements spaced at a second offset distance equidistantly upstream and downstream of the heating element, wherein the second offset distance is greater than the first offset distance, the method further comprising the step of:

periodically sampling the first pair of sensing elements if the flow rate is determined to be in a first range, and sampling the second pair of sensing elements if the flow rate is determined to be in a second range.

19. The method of claim 14, wherein the sampling step comprises measuring a relative amplitude and phase based on the heating signal at each of the upstream and downstream sensing elements.

20. The method of claim 19, wherein instantaneous flow rates are determined based on a table lookup of amplitude and phase values.

21. A medicament flow sensor comprising:

a manifold comprising a flow channel extending between an inlet and an outlet;

a sensor comprising a sensor face having;

a heating element; and

a first pair of sensing elements spaced equidistantly upstream and downstream of the heating element;

wherein the sensor face is exposed to fluid in the flow channel, and is substantially flush with or proud of a manifold surface of the flow channel.

22. The medicament flow sensor of claim 21, wherein the flow channel has a substantially rectangular cross section of known area adjacent to the sensor face.

23. The medicament flow sensor of claim 22, wherein the flow channel connects to a round cannula at the inlet and a round cannula at the outlet, and the flow channel comprises smooth transitions between portions of the flow channel with round cross section at the inlet and outlet, and the substantially rectangular cross section at the sensor face.

24. The medicament flow sensor of claim 21, wherein the volume of the flow channel is less than 30 microliters.

25. The medicament flow sensor of claim 21, further comprising a second sensor comprising a sensor face having a heating element and a pair of sensing elements spaced equidistantly upstream and downstream of the heating element, the second sensor located in a second portion of the flow channel having a different cross sectional area than the portion of the flow channel adjacent to the first sensor.

26. The medicament flow sensor of claim 21, wherein the sensor face is formed on a rigid substrate.

27. The medicament flow sensor of claim 21, wherein the sensor face is formed on a glass substrate.

28. The medicament flow sensor of claim 21, wherein the sensor face is formed on a rigid substrate having a thermal conductivity less than 2 W/mK.

29. The medicament flow sensor of claim 21, wherein the sensor face is formed of a polymer substrate having a thickness sufficient to resist deflection due to fluid pressure imparted by medicament within the flow channel during a dosing event.