Fluid delivery device with sensor

Patent metadata

Field	Value
Publication number	US-11724027-B2
Application number	US-202016884802-A
Country	US
Kind code	B2
Filing date	May 27, 2020
Priority date	Sep 23, 2016
Publication date	Aug 15, 2023
Grant date	Aug 15, 2023

Abstract

A wearable drug delivery device for monitoring unintended over-delivery and/or under-delivery of a stored liquid drug are provided. An absolute pressure sensor can be positioned within the fluid path of the drug delivery device. The absolute pressor sensor can detect both ambient pressure (e.g., absolute or atmospheric pressure) and relative pressure (gage or pumping pressure). Based on the detected pressures, the effects of external ambient pressure on air with the fluid path can be determined during both intended drug delivery events and unintended drug delivery events. In turn, under-delivery and/or over-delivery of the liquid drug can be determined. Based on the severity of the determined under-delivery or over-delivery of the liquid drug, alarms indicating different urgencies can be provided to the user.

First claim

What is claimed is:

1. An apparatus, comprising:
a reservoir configured to hold a liquid drug;
a fluid path component configured to be coupled to the reservoir;
a plunger configured to expel the liquid drug from the reservoir for delivery via the fluid path component;
a pressure transfer membrane coupled to the reservoir and operable to detect a pressure change within the reservoir;
a pressure sensor coupled to the pressure transfer membrane, wherein the pressure sensor is configured to detect atmospheric pressure and relative pressure from the pressure transfer membrane and output signals based on the detected atmospheric pressure and relative pressure;
a sensor interface coupled to the pressure sensor and operable to receive the signals output by the pressure sensor based on the detected atmospheric pressure and relative pressure; and
a monitoring component coupled to the sensor interface including circuitry, wherein the circuitry is operable to:
receive a first signal indicative of a first pressure from the sensor interface;
receive a second signal indicative of a second pressure from the sensor interface;
determine a delivery error amount of the liquid drug based on the first pressure and the second pressure;
actuate an alarm actuator to activate an alarm when a first threshold or a second threshold is passed.

2. The apparatus of claim 1 , wherein the pressure transfer membrane is operable to isolate the pressure sensor from the liquid drug.

3. The apparatus of claim 1 , wherein the pressure transfer membrane is operable to react to a displacement force caused by a pumping action to expel a liquid drug from the reservoir.

4. The apparatus of claim 1 , wherein the plunger is directed to expel the liquid drug from the reservoir during an intended delivery operation and is directed to not expel the liquid drug from the reservoir during an unintended delivery operation.

5. The apparatus of claim 1 , wherein:
the first pressure is a pressure at a start of a delivery operation for the liquid drug,
the second pressure is a pressure at an end of the delivery operation for the liquid drug, and
the circuitry of the monitoring component is configured to:
determine a fluid capacitance value of a fluid path used for the delivery operation of the liquid drug based on the first pressure and the second pressure;
determine an intended liquid drug delivery amount; and
determine the delivery error amount of the liquid drug based on the first pressure, the second pressure, the fluid capacitance value, and the intended liquid drug delivery amount.

6. The apparatus of claim 5 , wherein the alarm comprises at least one of a visual, an audible, and a tactile alert.

7. The apparatus of claim 1 , wherein the monitoring component indicates:
an over-delivery condition when the delivery error amount is greater than the first threshold, and
an under-delivery condition when the delivery error amount is less than the second threshold.

8. The apparatus of claim 7 , wherein the monitoring component is configured to generate the alert-alarm signal based on a determined severity of the over-delivery condition or the under-delivery condition.

9. The apparatus of claim 7 , wherein the monitoring component is configured to dynamically adjust the first and second thresholds.

10. The apparatus of claim 7 , further comprising:
a temperature sensor operable to provide a measure of temperature to the monitoring component, wherein the monitoring component is further configured to dynamically adjust the first and second thresholds based on a measured temperature or a de-rating factor based on a determined total amount of delivered liquid drug.

11. The apparatus of claim 5 , wherein the first signal is received at a first point in time and the second signal is received at a second point in time later than when the first signal is received.

12. The apparatus of claim 5 , wherein the fluid capacitance value changes in response to effective stiffness of a reservoir containing the liquid drug as the plunger is advanced further into the reservoir by a plunger drive mechanism coupled to the monitoring component.

13. An apparatus, comprising:
a reservoir configured to hold a liquid drug;
a fluid path component configured to form a fluid path from the reservoir;
a plunger configured to expel the liquid drug from the reservoir for delivery of the liquid drug via the fluid path formed by the fluid path component;
a pressure sensor installation port adjacent to the reservoir;
a pressure sensor operable to fit into the pressure sensor installation port, wherein:
the pressure sensor is configured to detect pressure from a pressure transfer membrane and output signals based on the detected pressure of the fluid path, and
the pressure sensor installation port is operable to isolate the pressure sensor from the fluid path;

a sensor interface coupled to the pressure sensor and operable to receive to the signals output by the pressure sensor based on the detected pressure; and
a monitoring component coupled to the sensor interface including circuitry, wherein the circuitry is operable to:
receive a first signal indicative of a first pressure from the sensor interface;
receive a second signal indicative of a second pressure from the sensor interface;
determine a delivery error amount of the liquid drug based on the first pressure and the second pressure; and
actuate an alarm actuator to activate an alarm when a first threshold or a second threshold is passed.

14. The apparatus of claim 13 , wherein the pressure sensor further comprises:
an extended portion, wherein the extended portion is operable to couple to the pressure sensor installation port to create a hermetic seal.

15. The apparatus of claim 14 , further comprising:
a radial point seal positioned within the installation port and operable to further isolate the pressure sensor from the fluid path of the reservoir, wherein the radial point seal is positionable along the extended portion.

16. The apparatus of claim 14 , further comprising:
a radial lip seal positioned within the installation port and forming a pointed end feature that is operable to bend when the pressure sensor and the extended portion are inserted into the installation port.

17. The apparatus of claim 13 , wherein the plunger is directed to expel the liquid drug from the reservoir during an intended delivery operation and is directed to not expel the liquid drug from the reservoir during an unintended delivery operation.

18. The apparatus of claim 13 , wherein:
the first pressure is a pressure at a start of a delivery operation for the liquid drug,
the second pressure is a pressure at an end of the delivery operation for the liquid drug, and
the circuitry of the monitoring component is configured to:
determine a fluid capacitance value of a fluid path used for the delivery operation of the liquid drug based on the first pressure and the second pressure;
determine an intended liquid drug delivery amount; and
determine the delivery error amount of the liquid drug based on the first pressure, and the second pressure, the fluid capacitance value, and the intended liquid drug delivery amount.

19. The apparatus of claim 18 , wherein the monitoring component indicates an over-delivery condition when the delivery error amount is greater than a first threshold and the monitoring component indicates an under-delivery condition when the delivery error amount is less than the second threshold.

20.

Assignees

• Insulet Corp

Inventors

• Allis Daniel
• Phillips Kenneth
• Coumans Jacob Anthony

Classifications

• A61M5/16854 Primary

  by monitoring line pressure · CPC title

• A61M5/1452

  pressurised by means of pistons · CPC title

• A61M5/14248

  of the skin patch type · CPC title

• A61M5/16831

  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 title

• G16H20/17

  delivered via infusion or injection · CPC title